Cleared Traditional

K946109 - CABOT MEDICAL REUSABLE BIPOLAR CUTTING ...

K946109 is an FDA 510(k) clearance for CABOT MEDICAL REUSABLE BIPOLAR CUTTING ..., manufactured by Cabot Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K946109 · Cabot Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
342d
Days
Class 2
Risk

K946109 is an FDA 510(k) clearance for the CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Cabot Medical Corp. (Langhorne, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cabot Medical Corp. devices

FDA 510(k) Submission Details - K946109

510(k) Number K946109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1994
Decision Date November 21, 1995
Days to Decision 342 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
212d slower than avg
Panel avg: 130d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

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 119
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K946109.
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K950836 · Hogan & Hartson · Mar 1995
OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
K950166 · Olympus America, Inc. · Feb 1995
HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP
K945764 · Aaron Medical Industries · Jan 1995