Cleared Traditional

K943476 - GIP/MEDI-GLOBE GOREIGN BODY GRASPERS

K943476 is an FDA 510(k) clearance for GIP/MEDI-GLOBE GOREIGN BODY GRASPERS, manufactured by Medi-Globe Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K943476 · Medi-Globe Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
149d
Days
Class 2
Risk

K943476 is an FDA 510(k) clearance for the GIP/MEDI-GLOBE GOREIGN BODY GRASPERS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Medi-Globe Corp. (Tempe, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 149 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 Medi-Globe Corp. devices

FDA 510(k) Submission Details - K943476

510(k) Number K943476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date December 15, 1994
Days to Decision 149 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 130d · This submission: 149d
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 39
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K943476.
OLYMPUS BASKET GRASPERS
K955063 · Olympus America, Inc. · Jan 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS
K955051 · Olympus America, Inc. · Jan 1996
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
K950434 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
BIOPSY SCISSORS
K942030 · Surgical Technologies, Inc. · Jun 1994
BIOSPSY FORCEPS
K920762 · Symbiosis Corp. · Aug 1992
WILSON-COOK RETRIEVAL & GRASPING FORCEPS
K902400 · Wilson-Cook Medical, Inc. · Aug 1990