Cleared Traditional

Multi-Functional Electrosurgical Knife

K212999 · Anrei Medical (Hangzhou) Co., Ltd. · Gastroenterology & Urology
Mar 2022
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K212999 is an FDA 510(k) clearance for the Multi-Functional Electrosurgical Knife, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Anrei Medical (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 21, 2022, 182 days after receiving the submission on September 20, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K212999 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2021
Decision Date March 21, 2022
Days to Decision 182 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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