Cleared Traditional

K873248 - GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS

K873248 is an FDA 510(k) clearance for GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS, manufactured by Medical Engineering Laboratory, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K873248 · Medical Engineering Laboratory, Inc. · Gastroenterology & Urology device
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Dec 1987
Decision
138d
Days
Class 2
Risk

K873248 is an FDA 510(k) clearance for the GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Medical Engineering Laboratory, Inc. (Shelby, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 138 days - within the typical 510(k) review window.

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 Medical Engineering Laboratory, Inc. devices

FDA 510(k) Submission Details - K873248

510(k) Number K873248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1987
Decision Date December 30, 1987
Days to Decision 138 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
8d slower than avg
Panel avg: 130d · This submission: 138d
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 K873248.
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
ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)
K874004 · Endovations · Dec 1987
RAT TOOTH GRASPING FORCEP (MODEL 23/20)
K874005 · Endovations · Dec 1987