Cleared Traditional

Sphincterotome / short-wire compatible, Sterile Sphincterotome

K210934 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology
Dec 2021
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K210934 is an FDA 510(k) clearance for the Sphincterotome / short-wire compatible, Sterile Sphincterotome, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on December 1, 2021, 247 days after receiving the submission on March 29, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K210934 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2021
Decision Date December 01, 2021
Days to Decision 247 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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