Cleared Special

K103688 - G-PROX EZ ENDOSCOPIC GRASPER

K103688 is an FDA 510(k) clearance for G-PROX EZ ENDOSCOPIC GRASPER, manufactured by Usgi Medical. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Special 510(k) pathway after a 28-day FDA review.

K103688 · Usgi Medical · Gastroenterology & Urology device
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Jan 2011
Decision
28d
Days
Class 2
Risk

K103688 is an FDA 510(k) clearance for the G-PROX EZ ENDOSCOPIC GRASPER. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Usgi Medical (San Clemente, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Usgi Medical devices

FDA 510(k) Submission Details - K103688

510(k) Number K103688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2010
Decision Date January 14, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K103688.
Grasping Forceps
K152802 · Micro-Tech (Nanjing) Co., Ltd. · Jan 2016
ENDOSCOPIC SUTURE CUTTER
K133736 · United States Endoscopy Group, Inc. · Jan 2014
ENDOSCOPIC RETRIEVAL DEVICE
K120084 · United States Endoscopy Group, Inc. · May 2012
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
K101298 · Endochoice, Inc. · Aug 2010
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
K051276 · Richard Wolf Medical Instruments Corp. · Oct 2005
STONE EXTRACTOR
K971123 · Phx Technologies Corp. · Jun 1997