Cleared Traditional

K932293 - CABOT MEDICAL BIPOLAR CUTTING FORCEPS

K932293 is an FDA 510(k) clearance for CABOT MEDICAL BIPOLAR CUTTING FORCEPS, 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 442-day FDA review.

K932293 · Cabot Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
442d
Days
Class 2
Risk

K932293 is an FDA 510(k) clearance for the CABOT MEDICAL 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 July 27, 1994 after a review of 442 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Cabot Medical Corp. devices

FDA 510(k) Submission Details - K932293

510(k) Number K932293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1993
Decision Date July 27, 1994
Days to Decision 442 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
312d slower than avg
Panel avg: 130d · This submission: 442d
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 K932293.
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MICROVASIVE INJECTION GOLD PROBE
K942301 · Boston Scientific Corp · Nov 1994
ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME
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K921029 · Biosearch Medical Products, Inc. · May 1992
BIPOLAR ENDOSTASIS PROBE, BEST (TM)
K915408 · Medical Devices, Inc. · Mar 1992