Cleared Traditional

K973259 - K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)

K973259 is an FDA 510(k) clearance for K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS), manufactured by Medical Creative Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K973259 · Medical Creative Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
12d
Days
Class 2
Risk

K973259 is an FDA 510(k) clearance for the K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS). Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Medical Creative Technologies, Inc. (Colmar, US). The FDA issued a Cleared decision on September 10, 1997 after a review of 12 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 Medical Creative Technologies, Inc. devices

FDA 510(k) Submission Details - K973259

510(k) Number K973259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1997
Decision Date September 10, 1997
Days to Decision 12 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 131d · This submission: 12d
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 K973259.
FLEXIBLE ENDOSCOPIC SCISSORS
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K973071 · Medical Engineering Laboratory, Inc. · Oct 1997
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K971202 · Comeg Endoskopie GmbH · May 1997
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K970982 · Tri-Med Specialties, Inc. · May 1997