N192876 N1 Ruling Active

The tariff classification of an intragastric balloon system from Costa Rica

Issued December 8, 2011 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 9021.90.8100

Headings: 9021

Product description

The merchandise described in your submission is referred to as the BioEnterics Intragastric Balloon (BIB™) System. Per the information you provided, the BIB™ System is a device that is intended for use in the treatment of moderately obese patients who have failed to control their weight by other means. The BIB™ System consists of a smooth silicone elastomer balloon that is endoscopically placed into a patient’s stomach. The system includes a placement catheter that facilitates the implantation of the balloon. Once implanted, the balloon is filled with 400cc to 700cc of saline, causing it to expand into a spherical shape. The inflated balloon partially fills the patient’s stomach, giving the patient a feeling of being full and thus reducing their food intake. The balloon is intended to stay in a user’s stomach for a period not exceeding six months. When the course of treatment is finished, the balloon can be deflated and removed endoscopically (using a specially designed removal instrument that was the subject of New York Ruling Letter N191555, dated November 22, 2011). The BIB™ System serves a function similar to that of the Lap Band system described in NYRL N008739, dated March 28, 2007. Both articles are intended to be implanted into an obese patient to reduce the amount of food they can consume. Ideally the reduction in consumption will lead to weight loss in the patient. We agree that

CBP rationale

the applicable subheading for the BIB™ System will be 9021.90.8100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" Appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability and parts and accessories thereof.

Full text

N192876 December 8, 2011 CLA-2-90:OT:RR:NC:N4:405 CATEGORY: Classification TARIFF NO.: 9021.90.8100 Daniel Hong Allergan 2525 Dupont Drive Irvine, CA 92612 RE: The tariff classification of an intragastric balloon system from Costa Rica Dear Mr. Hong: In your letter dated November 11, 2011, you requested a tariff classification ruling. No sample was provided. The merchandise described in your submission is referred to as the BioEnterics Intragastric Balloon (BIB™) System. Per the information you provided, the BIB™ System is a device that is intended for use in the treatment of moderately obese patients who have failed to control their weight by other means. The BIB™ System consists of a smooth silicone elastomer balloon that is endoscopically placed into a patient’s stomach. The system includes a placement catheter that facilitates the implantation of the balloon. Once implanted, the balloon is filled with 400cc to 700cc of saline, causing it to expand into a spherical shape. The inflated balloon partially fills the patient’s stomach, giving the patient a feeling of being full and thus reducing their food intake. The balloon is intended to stay in a user’s stomach for a period not exceeding six months. When the course of treatment is finished, the balloon can be deflated and removed endoscopically (using a specially designed removal instrument that was the subject of New York Ruling Letter N191555, dated November 22, 2011). The BIB™ System serves a function similar to that of the Lap Band system described in NYRL N008739, dated March 28, 2007. Both articles are intended to be implanted into an obese patient to reduce the amount of food they can consume. Ideally the reduction in consumption will lead to weight loss in the patient. We agree that the applicable subheading for the BIB™ System will be 9021.90.8100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" Appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability and parts and accessories thereof. The rate of duty will be free. 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 on World Wide Web at http://www.usitc.gov/tata/hts/. This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist J. Sheridan at (646) 733-3012. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division

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