Cleared Traditional

K792345 - RETRIEVABLE FORCEPS

K792345 is an FDA 510(k) clearance for RETRIEVABLE FORCEPS, manufactured by Mill-Rose Laboratory. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K792345 · Mill-Rose Laboratory · Gastroenterology & Urology device
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Dec 1979
Decision
31d
Days
Class 2
Risk

K792345 is an FDA 510(k) clearance for the RETRIEVABLE FORCEPS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Mill-Rose Laboratory (Walker, US). The FDA issued a Cleared decision on December 20, 1979 after a review of 31 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.

FDA 510(k) Submission Details - K792345

510(k) Number K792345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1979
Decision Date December 20, 1979
Days to Decision 31 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 131d · This submission: 31d
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 69
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K792345.
SPIRAL STONE AND RETRIEVAL BASKETS
K820429 · American Endoscopy, Inc. · Apr 1982
M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS
K800967 · Mr Associates, Inc. · May 1980
M.R. ASSOC. W TYPE GRASPING FORCEPS
K800976 · Mr Associates, Inc. · May 1980
FORCEPS, GRASPING
K760180 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976
K792345 · RETRIEVABLE FORCEPS
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