Cleared Traditional

K971123 - STONE EXTRACTOR

K971123 is an FDA 510(k) clearance for STONE EXTRACTOR, manufactured by Phx Technologies Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K971123 · Phx Technologies Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
92d
Days
Class 2
Risk

K971123 is an FDA 510(k) clearance for the STONE EXTRACTOR. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Phx Technologies Corp. (Denton, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 92 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 Phx Technologies Corp. devices

FDA 510(k) Submission Details - K971123

510(k) Number K971123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1997
Decision Date June 27, 1997
Days to Decision 92 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
39d faster than avg
Panel avg: 131d · This submission: 92d
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 K971123.
TELEMED SYSTEMS RETRIEVAL BASKET
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TRI TALON RETRIEVAL FORCEPS
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K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
K973259 · Medical Creative Technologies, Inc. · Sep 1997
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS
K971202 · Comeg Endoskopie GmbH · May 1997
T-RX RETRIEVAL FORCEPS
K970982 · Tri-Med Specialties, Inc. · May 1997
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
K965176 · Pilling Weck Group · Mar 1997