Cleared Traditional

K972505 - RESUABLE HOT BIOPSY FORCEPS

K972505 is the FDA 510(k) clearance for RESUABLE HOT 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 77-day FDA review.

K972505 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
77d
Days
Class 2
Risk

K972505 is an FDA 510(k) clearance for the RESUABLE HOT BIOPSY FORCEPS. 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 September 18, 1997 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K972505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1997
Decision Date September 18, 1997
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
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.

Regulatory Peers - KGE Forceps, Biopsy, Electric

All 21
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K972505.
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · Olympus Medical Systems Corporation · Dec 2006
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · Wilson-Cook Medical, Inc. · Mar 2000
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K955052 · Olympus America, Inc. · Jan 1996
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445 · Olympus America, Inc. · May 1995
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
K944765 · KARL STORZ Endoscopy-America, Inc. · Mar 1995