Cleared Traditional

K951421 - GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES

K951421 is an FDA 510(k) clearance for GLOBAL MEDICAL PRODUCTS CHIBA, manufactured by Global Medical Products, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K951421 · Global Medical Products, Ltd. · Gastroenterology & Urology device
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Nov 1995
Decision
233d
Days
Class 2
Risk

K951421 is an FDA 510(k) clearance for the GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GR.... Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Global Medical Products, Ltd. (Clearwater, US). The FDA issued a Cleared decision on November 16, 1995 after a review of 233 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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.

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FDA 510(k) Submission Details - K951421

510(k) Number K951421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1995
Decision Date November 16, 1995
Days to Decision 233 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 131d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

Product Code FCG Biopsy Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - FCG Biopsy Needle

All 78
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K951421.
DAUM BIOPSYNEEDLE
K961185 · Ferguson Medical · Apr 1996
LAURUS NEEDLE CORE BIOPSY SYSTEM
K960317 · Laurus Medical Corp. · Mar 1996
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K943304 · Olympus America, Inc. · Dec 1995
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
K954231 · Promex, Inc. · Sep 1995
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
K954155 · Promex, Inc. · Sep 1995
B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
K950982 · B. Braun of America, Inc. · Apr 1995