CLA-2-30:OT:RR:NC:N3:138
Brian Smith
Steris Corporation
5960 Heisley Rd Mentor, OH 44060
RE: The tariff classification of the ASCENDO™ Submucosal Lifting Agent from South Korea
Dear Mr. Smith:
In your letter dated December 5, 2024, you requested a tariff classification ruling.
ASCENDO™ Submucosal Lifting Agent is a single-use, sterile endoscopic lifting solution used in endoscopic procedures to create a cushion-like space between the mucosa and underlining tissue to lift polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device. The main materials of the solution are sodium hyaluronate, methylene blue and normal saline. It is avaible by prescription only in a prefilled disposable 5 mL syringe.
The instructions for use you submitted states that the ASCENDO™ Submucosal Lifting Agent is indicated for endoscopic resection procedures in the upper and the lower gastrointestinal tract, such as the esophagus, the stomach, the intestine and the rectum. It is injected into the submucosa, beneath the lesion to be excised and designed to provide a submucosal cushion of optimal height and duration, allowing the endoscopist an easy and safe resection procedure (polypectomy, endoscopic mucosal resection (EMR), hybrid EMR and endoscopic submucosal dissection (ESD)). The submucosal lifting agent helps to clarify the area where it is injected, to assist the clinician in visualizing the margins of the target lesion and performing the resection procedure, thereby decreasing the risk of damaging the external muscular layer, which could lead to perforation.
The applicable subheading for the ASCENDO™ Submucosal Lifting Agent will be 3004.90.1000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Containing antigens or hyaluronic acid or its sodium salt.” 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 at https://hts.usitc.gov/.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
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 Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division