Ms. Iliana Fuller
Manager, Global Trade Compliance
Allergan, Inc.
2525 Dupont Drive
Irvine, CA 92623

RE: The tariff classification of three Lap-band related items from Ireland

Dear Ms. Fuller:

In your letter dated April 18, 2008, you requested a tariff classification ruling. No sample was provided. You did provide a 25 page “Summary and Effectiveness Data,” but you did not indicate, where, if anywhere, there was specific information on these items.

You also enclosed another letter from you dated April 18, 2007. Per NISA M. Bender’s telephone call to you, the 2007 was a typo for 2008. In that letter, you proposed classification for all three items in 9021.90.8100.

You submitted additional information with Descriptions and other information regarding the Calibration Tube and the Access Port Needle later in April in response to our telephone request.

Regarding the BioEnterics Calibration Tube, you state, in your letter: The BioEnterics Calibration Tube is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures including gastrectomy, fundoplication, gastric banding, vertical banded gastroplasty, and gastric bypass. The catheter provides visible and tactile delineation of the antrum of the stomach, along with the ability to decompress the stomach, drain and remove gastric fluid, and size a gastric pouch. The BioEnterics Calibration Tube is supplied non-sterile and for single use only.

The Description submitted later states:

The dual lumen BioEnterics Calibration Tube utilizes one lumen for drainage, suction, and irrigation, and the second lumen to inflate/deflate the fixation/balloon. The catheter is attached to a 36 inch suction tubing and a 6 inch tubing, with a stopcock for filling the balloon.

It is thus very similar to the Balloon Suction Catheter classified in 9021.39.00 in New York Ruling Letter N008739-105, mailed to you on March 28, 2007. It may have additional markings along its side to assist in simple measurements, but that does not change it principal function.

Regarding the BioEnterics Access Port Needle, you state, in your letter: The Access Port Needle is a non-coring deflected tip (“Huber tip”) needle for use with the LAP-BAND AP. The needle is used to penetrate the septum of the LAP-BAND AP access port during adjustment of the LAP-BAND AP Adjustable Gastric Band. The Access Port Needle is available in two lengths - 20 gauge, 89 mm (3.5 inches) and 51 mm (2.0 inches). The shaft is 304-grade stainless steel, and the needle has a plastic hub. Each needle is supplied sterile.

The later submission implies that they are similar to “standard hypodermic needles” in that it warns against their use, in that “these may cause leaks.” The Access Port is clearly inside the patient, not external.

Regarding both these items, whether or not they could be considered parts or accessories of appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability, when imported separately as replacements, as here, they are classified in the respective headings which cover them in themselves. See Note 2-a to HTSUS Chapter 90. The applicable subheading for the BioEnterics Calibration Tube will be 9018.39.00, Harmonized Tariff Schedule of the United States (HTSUS), which provides for, inter alia, catheters, cannulae and the like and the parts and accessories thereof. The rate of duty will be Free.

The applicable subheading for the BioEnterics Access Port Needle will be 9018.32.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Instruments and appliances used in medical, surgical, dental or veterinary sciences - Syringes, needles, catheters, cannulae and the like - Tubular metal needles and needles for sutures. The rate of duty will be Free. Regarding the Lap-Band Closure Tool, we have not found a description of what it does and how it does it. We are returning your request for a ruling, and any related samples, exhibits, etc. We need additional information in order to issue a ruling. Please submit the information described below:

Descriptive literature or a detailed explanation on the use of the item.

Descriptive literature or a detailed explanation on how the item operates/functions.

Also include a statement as to whether classification advice has been sought from a Customs officer; and if so, from whom, and what advice was rendered, if any.

If you decide to resubmit your request regarding the Lap Band Closure Tool, please include all of the material that we have returned to you regarding it and mail your request to U.S. Customs and Border Protection, Customs Information Exchange, 10th Floor, One Penn Plaza, New York, NY 10119, attn: Binding Rulings Section. If your request was submitted electronically and the information required does not involve sending a sample, you can re-submit your request and the additional information electronically.

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

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 above, contact National Import Specialist J. Sheridan at 646-733-3012.


Robert B. Swierupski
National Commodity
Specialist Division