The tariff classification of G2-W Singulator from Costa Rica.

N358892 March 9, 2026 CLA-2-90:OT:RR:NC:N3:143 CATEGORY: Classification TARIFF NO.: 9018.50.0000; 9817.00.96 Salvador Parra DSV Air & Sea 1425 Corporate Center Dr, Ste 900 San Diego, CA 92154 RE: The tariff classification of G2-W Singulator from Costa Rica. Dear Mr. Parra: In your letter dated February 13, 2026, you requested a tariff classification ruling on behalf of your client, Glaukos Corporation. You state Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. The item in consideration is the G2-W Singulator, a specifically designed component of the iStent inject W Trabecular Micro-Bypass System. The G2-W Singulator is an internal, non-implantable mechanical component of the system that advances and deploys the trabecular micro-bypass stent. It is made of nickel-titanium alloy and housed inside the distal micro-insertion tube of the injector. Its sole function is to mechanically push the preloaded stent into the patient’s trabecular meshwork; the stent itself is not contained within the singulator. During use, the singulator advances forward, pushing the stent from behind out of the micro insertion tube and into position. The G2-W Singulator does not cut tissue, transport fluids or remain implanted in the patient; it is discarded after the procedure. The iStent inject W Trabecular Micro-Bypass System consists of an injector and two trabecular bypass stents, which are implanted into the trabecular meshwork in patients with documented glaucomatous optic neuropathy. The system is intended for use in conjunction with cataract surgery in adult patients with mild to moderate primary open-angle glaucoma. Its primary medical purpose is to lower intraocular pressure, reduce mechanical and ischemic stress on the optic nerve, slow or halt progressive visual loss, and reduce reliance on chronic medications. The system is not designed, approved, or marketed for unrelated ophthalmic procedures or for implantations in individuals without established glaucoma. The iStent inject W Trabecular Mirco-Bypass System helps mitigate the progression of permanent visual impairment in patients with mild to moderate glaucoma. As you noted, patients at these stages already have an existing chronic visual impairment, with documented optic nerve damage and measurable visual field impairment confirmed through clinical evaluation at the time of implantation. Lost vision cannot be restored, and disease progression continues without intervention. Peripheral visual field loss directly affects driving, navigation, reading, occupational performance, and independent living. Therefore, glaucoma significantly affects the major life activity of seeing. The applicable subheading for G2-W Singulator will be 9018.50.0000, HTSUS, which provides for “]i]nstruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphy apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: [o]ther ophthalmic instruments and appliances and parts and accessories thereof.” The general rate of duty will be free. In your submission you requested consideration of a secondary classification under 9817.00.96, Harmonized Tariff Schedule of the United Sates (HTSUS), which applies to articles and parts and accessories of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles . . . Other.” The term “blind or other physically or mentally handicapped person includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection (CBP): (1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped. The iStent inject W Trabecular Micro-Bypass System is designed to create permanent anatomical bypass pathways, lower intraocular pressure and slow the progression of irreversible optic nerve damage in glaucoma patients. You assert that patients with mild to moderate glaucoma typically have an existing chronic visual impairment, documented optic nerve damage and measurable visual field impairment, which affects the major life activity of seeing. Based on the information provided, it is our opinion that patients suffering from mild to moderate glaucoma are considered physically handicapped as defined in Chapter 98, Subchapter XVII, U.S. Note 4(a). The iStent inject W Trabecular Micro-Bypass System is specifically designed for the benefit of such persons and therefore, is eligible for duty-free treatment under subheading 9817.00.96, HTSUS. Additionally, the G2-W Singulator, a part specifically designed for and manufactured for exclusive use with the iStent inject W Trabecular Micro-Bypass System, is also eligible for duty-free treatment under subheading 9817.00.96, HTSUS. The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Dionisia Melman at dionisia.y.melman@cbp.dhs.gov. Sincerely, (for) James Forkan Designated Official Performing the Duties of the Division Director National Commodity Specialist Division