Cleared Traditional

K920762 - BIOSPSY FORCEPS

K920762 is an FDA 510(k) clearance for BIOSPSY FORCEPS, manufactured by Symbiosis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K920762 · Symbiosis Corp. · Gastroenterology & Urology device
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Aug 1992
Decision
189d
Days
Class 2
Risk

K920762 is an FDA 510(k) clearance for the BIOSPSY FORCEPS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on August 26, 1992 after a review of 189 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 Symbiosis Corp. devices

FDA 510(k) Submission Details - K920762

510(k) Number K920762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1992
Decision Date August 26, 1992
Days to Decision 189 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 130d · This submission: 189d
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 38
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K920762.
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS
K955051 · Olympus America, Inc. · Jan 1996
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
K950434 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
BIOPSY SCISSORS
K942030 · Surgical Technologies, Inc. · Jun 1994
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