Cleared Traditional

K925361 - BIOPSY FORCEPS

K925361 is the FDA 510(k) clearance for BIOPSY FORCEPS by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
28d slower than avg
Panel avg: 130d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.