Cleared Traditional

Single Use Hot Biopsy Forceps FD-231 (K171916) - FDA 510(k) Clearance

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

K171916 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Oct 2017
Decision
109d
Days
Class 2
Risk

K171916 is an FDA 510(k) clearance for the Single Use Hot Biopsy Forceps FD-231. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 13, 2017 after a review of 109 days - within the typical 510(k) review window.

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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K171916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2017
Decision Date October 13, 2017
Days to Decision 109 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
21d faster than avg
Panel avg: 130d · This submission: 109d
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 Consultant

Olympus Corporation of the Americas
Sheri L. Musgnung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGE Forceps, Biopsy, Electric

All 19
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K171916.
Disposable Hot Biopsy Forceps
K180018 · Micro-Tech (Nanjing) Co., Ltd. · Jul 2018
Ensizor Monopolar Endoscopic Scissors
K180134 · Slater Endoscopy, LLC · Jun 2018
Captura® Disposable Hot Biopsy Forceps
K171973 · Wilson-Cook Medical, Inc. · Mar 2018
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · Wilson-Cook Medical, Inc. · Mar 2000
RESUABLE HOT BIOPSY FORCEPS
K972505 · United States Endoscopy Group, Inc. · Sep 1997