Cleared Traditional

K192339 - TeslaTome Bipolar Sphincterotome

K192339 is the FDA 510(k) clearance for TeslaTome Bipolar Sphincterotome by Wilson-Cook Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K192339 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
155d
Days
Class 2
Risk

K192339 is an FDA 510(k) clearance for the TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 30, 2020 after a review of 155 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K192339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 130d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 114
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K192339.
ORISE ProKnife
K200404 · Boston Scientific Corporation · Dec 2020
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
K192342 · Hangzhou AGS MedTech Co., Ltd. · May 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
K192905 · Creo Medical, Ltd. · Mar 2020
Single Use Balloon Dilator V (with knife)
K193039 · Olympus Medical Systems Corp. · Dec 2019
Rezum System
K191505 · Nxthera (A Boston Scientific Company) · Aug 2019
Aqua Medical RF Vapor System
K183595 · Aqua Medical, Inc. · Jun 2019