Cleared Special

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

K243568 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology
Jan 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K243568 is an FDA 510(k) clearance for the Teslatome Bipolar Sphincterotome; Tesla BiCord 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 17, 2025, 60 days after receiving the submission on November 18, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K243568 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2024
Decision Date January 17, 2025
Days to Decision 60 days
Submission Type Special
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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