Cleared Traditional

K881332 - DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & ...

K881332 is the FDA 510(k) clearance for DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & ... by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code OCZ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K881332 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Apr 1988
Decision
29d
Days
Class 2
Risk

K881332 is an FDA 510(k) clearance for the DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 27, 1988 after a review of 29 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K881332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1988
Decision Date April 27, 1988
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K881332.
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
K950434 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
BIOSPSY FORCEPS
K920762 · Symbiosis Corp. · Aug 1992
WILSON-COOK RETRIEVAL & GRASPING FORCEPS
K902400 · Wilson-Cook Medical, Inc. · Aug 1990
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