Cleared Traditional

K925361 - BIOPSY FORCEPS, ELECTRIC

K925361 is an FDA 510(k) clearance for BIOPSY FORCEPS, manufactured by United States Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K925361 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Mar 1993
Decision
158d
Days
Class 2
Risk

K925361 is an FDA 510(k) clearance for the BIOPSY FORCEPS, ELECTRIC. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 29, 1993 after a review of 158 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 United States Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K925361

510(k) Number K925361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date March 29, 1993
Days to Decision 158 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 131d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGE Device Classification - Class 2, Special Controls

Product Code KGE Forceps, Biopsy, Electric
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 - KGE Forceps, Biopsy, Electric

All 36
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K925361.
HOT BIOPSY FORCEPS
K943078 · Intl. Medical, Inc. · Nov 1994
SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
K932266 · Symbiosis Corp. · Mar 1994
DISPOSABLE HOT BIOPSY FORCEPS
K923470 · Wilson-Cook Medical, Inc. · Apr 1993
HOT BIOPSY FORCEPS
K910964 · Symbiosis Corp. · May 1991
BIPOLAR BIOPSY FORCEPS
K904985 · Everest Medical Corp. · Jan 1991
PORGES HOT BIOPSY FORCEPS
K896537 · Porges Corp. · Nov 1989