Cleared Traditional

K896502 - PORGES BIOPSY & FOREIGN BODY FORCEPS

K896502 is an FDA 510(k) clearance for PORGES BIOPSY & FOREIGN BODY FORCEPS, manufactured by Porges Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K896502 · Porges Corp. · Gastroenterology & Urology device
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Jan 1990
Decision
68d
Days
Class 2
Risk

K896502 is an FDA 510(k) clearance for the PORGES BIOPSY & FOREIGN BODY FORCEPS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Porges Corp. (Gary, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 68 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 Porges Corp. devices

FDA 510(k) Submission Details - K896502

510(k) Number K896502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1989
Decision Date January 22, 1990
Days to Decision 68 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 130d · This submission: 68d
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 39
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K896502.
BIOPSY SCISSORS
K942030 · Surgical Technologies, Inc. · Jun 1994
BIOSPSY FORCEPS
K920762 · Symbiosis Corp. · Aug 1992
WILSON-COOK RETRIEVAL & GRASPING FORCEPS
K902400 · Wilson-Cook Medical, Inc. · Aug 1990
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
K881332 · Baxter Healthcare Corp · Apr 1988
3 FRENCH FLEXIBLE BIOPSY FORCEPS
K881399 · Cook Urological, Inc. · Apr 1988
HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)
K874003 · Endovations · Dec 1987