Cleared Traditional

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

K192339 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology
Jan 2020
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K192339 is an FDA 510(k) clearance for the TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on January 30, 2020, 155 days after receiving the submission on August 28, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K192339 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2019
Decision Date January 30, 2020
Days to Decision 155 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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