Cleared Traditional

K062517 - ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES

K062517 is an FDA 510(k) clearance for ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES, manufactured by Olympus Medical Systems Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K062517 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
116d
Days
Class 2
Risk

K062517 is an FDA 510(k) clearance for the ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 116 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.

FDA 510(k) Submission Details - K062517

510(k) Number K062517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date December 22, 2006
Days to Decision 116 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
15d faster than avg
Panel avg: 131d · This submission: 116d
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 45
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K062517.
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010
MULTI-BITE HOT BIOPSY FORCEPS
K090796 · Endo-Therapeutics, Inc. · Nov 2009
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
K090583 · Apollo Endosurgery, Inc. · Jun 2009
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
K022751 · Medical Device Services · Nov 2002
HORIZONS REUSABLE HOT BIOPSY FORCEPS
K022243 · Horizons Intl. Corp. · Oct 2002
HORIZONS HOT BIOPSY FORCEPS
K021706 · Horizons Intl. Corp. · Jun 2002
K062517 · ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
Download PDF FDA Summary Olympus Medical Syste…