Cleared Traditional

K012074 - XBO1-824-18/19/20 BIOPSY FORCEPS

K012074 is an FDA 510(k) clearance for XBO1-824-18/19/20 BIOPSY FORCEPS, manufactured by The Olympus Optical Co.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K012074 · The Olympus Optical Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
85d
Days
Class 2
Risk

K012074 is an FDA 510(k) clearance for the XBO1-824-18/19/20 BIOPSY FORCEPS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on September 25, 2001 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 The Olympus Optical Co. devices

FDA 510(k) Submission Details - K012074

510(k) Number K012074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date September 25, 2001
Days to Decision 85 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
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCZ Device Classification - Class 2, Special Controls

Product Code OCZ Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.
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 - OCZ Endoscopic Grasping/cutting Instrument, Non-powered

All 58
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K012074.
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
K101298 · Endochoice, Inc. · Aug 2010
MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
K072684 · Mondeal North America, Inc. · Jan 2008
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
K051276 · Richard Wolf Medical Instruments Corp. · Oct 2005
FLEXIBLE ENDOSCOPIC SCISSORS
K010412 · Telemed Systems, Inc. · Apr 2001
TELEMED SYSTEMS RETRIEVAL BASKET
K974300 · Telemed Systems, Inc. · Dec 1997
TRI TALON RETRIEVAL FORCEPS
K973071 · Medical Engineering Laboratory, Inc. · Oct 1997