Cleared Traditional

K051276 - HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM

K051276 is an FDA 510(k) clearance for HYSAFE MICRO MODULAR FORCEPS AND SCISSO..., manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K051276 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
164d
Days
Class 2
Risk

K051276 is an FDA 510(k) clearance for the HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on October 28, 2005 after a review of 164 days - an extended review 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: 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K051276

510(k) Number K051276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2005
Decision Date October 28, 2005
Days to Decision 164 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
33d slower than avg
Panel avg: 131d · This submission: 164d
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 57
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K051276.
ENDOSCOPIC RETRIEVAL DEVICE
K120084 · United States Endoscopy Group, Inc. · May 2012
G-PROX EZ ENDOSCOPIC GRASPER
K103688 · Usgi Medical · Jan 2011
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
K101298 · Endochoice, Inc. · Aug 2010
XBO1-824-18/19/20 BIOPSY FORCEPS
K012074 · The Olympus Optical Co. · Sep 2001
FLEXIBLE ENDOSCOPIC SCISSORS
K010412 · Telemed Systems, Inc. · Apr 2001
TELEMED SYSTEMS RETRIEVAL BASKET
K974300 · Telemed Systems, Inc. · Dec 1997