Cleared Traditional

Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

K220790 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Gastroenterology & Urology
Jun 2022
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K220790 is an FDA 510(k) clearance for the Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on June 27, 2022, 102 days after receiving the submission on March 17, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K220790 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2022
Decision Date June 27, 2022
Days to Decision 102 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FDI — Snare, Flexible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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