Cleared Traditional

OLYMPUS FD-5 HOT BIOPSY FORCEPS (K951445) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951445 · Olympus America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
35d
Days
Class 2
Risk

K951445 is an FDA 510(k) clearance for the OLYMPUS FD-5 HOT BIOPSY FORCEPS. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on May 3, 1995 after a review of 35 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 Olympus America, Inc. devices

Submission Details

510(k) Number K951445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1995
Decision Date May 03, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
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 14
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K951445.
Captura® Disposable Hot Biopsy Forceps
K171973 · Wilson-Cook Medical, Inc. · Mar 2018
Single Use Hot Biopsy Forceps FD-231
K171916 · Olympus Medical Systems Corp. · Oct 2017
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
K944765 · KARL STORZ Endoscopy-America, Inc. · Mar 1995