Cleared Traditional

Single Use Endoscope Valves Set

K192048 · Anrei Medical (Hangzhou) Co., Ltd. · Gastroenterology & Urology

May 2020

Decision

288d

Days

Class 2

Risk

About This 510(k) Submission

K192048 is an FDA 510(k) clearance for the Single Use Endoscope Valves Set, a Endoscope Channel Accessory (Class II — Special Controls, product code ODC), submitted by Anrei Medical (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 14, 2020, 288 days after receiving the submission on July 31, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K192048 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2019
Decision Date	May 14, 2020
Days to Decision	288 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	ODC — Endoscope Channel Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Give The Endoscope Channel Additional Or Improved Functionality.