Cleared Traditional

Single-use Flexible Ureteroscope

K250785 · Hunan Vathin Medical Instrument Co., Ltd. · Gastroenterology & Urology
May 2025
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K250785 is an FDA 510(k) clearance for the Single-use Flexible Ureteroscope, a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Hunan Vathin Medical Instrument Co., Ltd. (Xiangtan, CN). The FDA issued a Cleared decision on May 6, 2025, 53 days after receiving the submission on March 14, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K250785 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2025
Decision Date May 06, 2025
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FGB — Ureteroscope And Accessories, Flexible/rigid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

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