Cleared Special

Single-use Ureteral Access Sheath

K251599 · Hunan Vathin Medical Instrument Co., Ltd. · Gastroenterology & Urology
Jul 2025
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K251599 is an FDA 510(k) clearance for the Single-use Ureteral Access Sheath, a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by Hunan Vathin Medical Instrument Co., Ltd. (Xingtan, CN). The FDA issued a Cleared decision on July 3, 2025, 37 days after receiving the submission on May 27, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K251599 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2025
Decision Date July 03, 2025
Days to Decision 37 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FED — Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.

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