Cleared Traditional

K970982 - T-RX RETRIEVAL FORCEPS

K970982 is an FDA 510(k) clearance for T-RX RETRIEVAL FORCEPS, manufactured by Tri-Med Specialties, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K970982 · Tri-Med Specialties, Inc. · Gastroenterology & Urology device
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May 1997
Decision
52d
Days
Class 2
Risk

K970982 is an FDA 510(k) clearance for the T-RX RETRIEVAL FORCEPS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Tri-Med Specialties, Inc. (Lenexa, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 52 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 Tri-Med Specialties, Inc. devices

FDA 510(k) Submission Details - K970982

510(k) Number K970982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1997
Decision Date May 09, 1997
Days to Decision 52 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
79d faster than avg
Panel avg: 131d · This submission: 52d
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 58
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K970982.
K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
K973259 · Medical Creative Technologies, Inc. · Sep 1997
STONE EXTRACTOR
K971123 · Phx Technologies Corp. · Jun 1997
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS
K971202 · Comeg Endoskopie GmbH · May 1997
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
K965176 · Pilling Weck Group · Mar 1997
OLYMPUS BASKET GRASPERS (UROLOGY)
K961611 · Olympus America, Inc. · Jul 1996
OLYMPUS FG SERIES GRASPING FORCEPS
K955066 · Olympus America, Inc. · Jan 1996