Classification of the U-Clip and the Spyder; Protest No. 2604-08-100001

HQ H024415 April 6, 2009 CLA-2 OT:RR:CTF:TCM H024415 RM CATEGORY: Classification TARIFF NO.: 9018.90.80 Port Director Nogales Service Port U.S. Customs and Border Protection 9 North Grand AvenueNogales, AZ 85621 RE: Classification of the U-Clip and the Spyder; Protest No. 2604-08-100001 Dear Port Director: The following is our decision regarding the Application for Further Review (“AFR”) of Protest No. 2604-08-100001, timely filed by Medtronic, Inc., concerning the classification of Medtronic’s “U-Clip” and “Spyder” devices under the Harmonized Tariff Schedule of the United States (“HTSUS”). Protestant entered the merchandise on various dates between January 31, 2007, and February 27, 2007, under subheading 9018.90.80, HTSUS, as: “Instruments and appliances used in surgical sciences …: Other instruments and appliances …: Other.” U.S. Customs and Border Protection (“CBP”) liquidated the goods on various dates between December 14, 2007, and December 28, 2007, under subheading 7508.90.50, HTSUS, as “Other articles of nickel: Other: Other.” This Protest and AFR were timely filed on January 8, 2008. FACTS: This Protest concerns Medtronic’s “U-Clip” and “Spyder” (pictured below), devices used during vascular and cardiac surgery to join severed veins, arteries and organs. The U-Clip is a self-closing clip attached to a conventional surgical needle by a flexible member. It is composed of nitinol, a metal alloy consisting of nickel and titanium that returns to its original configuration after being flexed. According to our research gathered from the importer’s website, after the needle is pierced into the flesh, the device connects the vessels and then retracts when released, thereby forming a ring. The self-closing clip makes knot-tying and suture management during surgery unnecessary.
  U-Clip The Spyder is a device that simultaneously delivers six U-Clips. It is used primarily by heart surgeons during coronary artery bypass surgery to link bypass grafts and other blood vessels without clamping the aorta.
  Spyder ISSUE: Whether the U-Clip and Spyder are classified under heading 7508, HTSUS, as “Other articles of nickel,” or under heading 9018, HTSUS, as “Instruments and appliances used in surgical sciences.” LAW AND ANALYSIS: Initially, we note that the matter is protestable under 19 U.S.C. § 1514(a)(2) as a decision on classification. The Protest was timely filed within 180 days of liquidation for all involved entries (Miscellaneous Trade and Technical Corrections Act of 2004, Pub.L. 108-429, § 2103(2)(B)(ii), (iii) (codified as amended at 19 U.S.C. § 1514(c)(3) (2006)). Further Review of Protest No. 2604-08-100001 was properly accorded to Protestant pursuant to 19 C.F.R. § 174.24(c) because it involves matters previously ruled upon by the Commissioner of Customs or by the Customs courts, but facts are alleged or legal arguments are presented which were not considered at the time of the original ruling. Specifically, Protestant provided documentation to support the claim that the goods are medical devices used during vascular and cardiac surgery, not general purpose clips. Classification under the HTSUS is made in accordance with the General Rules of Interpretation (“GRIs”). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order. The 2007 HTSUS headings under consideration are as follows: 7508 Other articles of nickel: 7508.90 Other: 7508.90.50 Other … 9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: 9018.90 Other instruments and appliances and parts and accessories thereof: Other: 9018.90.80 Other … The Harmonized Commodity Description and Coding System Explanatory Notes (“ENs”) constitute the official interpretation of the Harmonized System at the international level. While not legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989). The ENs to heading 7508, HTSUS, state, in part: (B) OTHER This group covers all articles of nickel other than those covered by the preceding group or by the preceding headings of this Chapter or by Note 1 to Section XV, or articles specified or included in Chapter 82 or 83, or more specifically covered elsewhere in the Nomenclature. The ENs to heading 9018, HTSUS, state, in part: This heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc. Instruments and appliances for anatomical or autoptic work, dissection, etc., are also included, as are, under certain conditions, instruments and appliances for dental laboratories (see Part (II) below). The instruments of the heading may be made of any material (including precious metals). This heading does not cover: (a) Sterile catgut and other sterile material for surgical sutures, sterile laminaria and sterile laminaria tents (heading 30.06). * * * (I) INSTRUMENTS AND APPLIANCES FOR HUMAN MEDICINE OR SURGERY This group includes: Instruments which may be used under the same names for several purposes, for example: Needles (for sutures, ligatures, vaccination, blood tests, hypodermic needles, etc.). * * * (15) Clips (suture, etc.). * * * (17) Surgical staplers for inserting staples to close a wound. Heading 9018, HTSUS, provides in relevant part for “[i]nstruments and appliances used in … surgical sciences.” The ENs to heading 9018 list clips (suture, etc.) and surgical staplers as exemplars of instruments used only in professional practice (e.g., by surgeons) to operate. The U-Clip is not a general-purpose clip. It is used solely during vascular and cardiac surgery to join vessels and organs. As such, it is classified under heading 9018, HTSUS. See Headquarters Ruling Letter (“HQ”) H035567, dated December 17, 2008. See also HQ 965845, 965846, and 965847, dated November 7, 2002 (surgical needles with sutures attached classified under heading 9018, HTSUS). Classification under heading 7808, HTSUS, is thereby precluded, as it is limited to articles not more specifically provided elsewhere in the tariff. See EN 75.08(B). Insofar as the Spyder is a device used exclusively in surgery to connect tissue inside the human body, we conclude that it is also classified under heading 9018, HTSUS, as instruments and appliances used in surgical sciences. It is analogous to a surgical stapler in that they both serve the purpose of linking human tissue. HOLDING: Under the authority of GRI 1, the U-Clip and Spyder are classified under heading 9018, specifically subheading 9018.90.80, HTSUS, which provides for: “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Other instruments and appliances and parts and accessories thereof: Other.” The 2007 column one, general rate of duty is: Free. Since reclassification of the merchandise as indicated above will result in a lower rate of duty than the liquidated rate, you are instructed to allow the Protest in full. In accordance with the Protest/Petition Processing Handbook (HB 3500-08A, December 2007, pp. 24 and 26), you are to mail this decision, together with the CBP Form 19, to the Protestant no later than 60 days from the date of this letter. Any reliquidation of the entry in accordance with the decision must be accomplished prior to mailing of the decision. Sixty days from the date of the decision the Office of International Trade will make the decision available to CBP personnel, and to the public on the CBP Home Page on the World Wide Web at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution. Sincerely, Myles B. Harmon, Director Commercial and Trade Facilitation Division