Cleared Traditional

K934256 - GLOBAL MEDICAL CUTTING BIOPSY NEEDLE

K934256 is an FDA 510(k) clearance for GLOBAL MEDICAL CUTTING BIOPSY NEEDLE, manufactured by Global Medical Prods, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K934256 · Global Medical Prods, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
209d
Days
Class 2
Risk

K934256 is an FDA 510(k) clearance for the GLOBAL MEDICAL CUTTING BIOPSY NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Global Medical Prods, Inc. (Road Town, Tortola, VG). The FDA issued a Cleared decision on March 28, 1994 after a review of 209 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.

FDA 510(k) Submission Details - K934256

510(k) Number K934256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date March 28, 1994
Days to Decision 209 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 131d · This submission: 209d
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 127
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K934256.
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K945146 · Promex, Inc. · Dec 1994
MODIFIED BIOPSY NEEDLE
K945133 · Biopsys Medical, Inc. · Nov 1994
THE BIOPSY TOOL
K941563 · Citation Medical Corp. · Sep 1994
COAXIAL BIOPSY NEEDLE
K936194 · Bard Gynecology and Radiology · Mar 1994
BIP-COAX-SYSTEM
K915801 · Uni-Quatro Industries Canada, Inc. · Mar 1994
BIP BIOPSY NEEDLE MODIFICATION
K934370 · Bip USA, Inc. · Mar 1994
K934256 · GLOBAL MEDICAL CUTTING BIOPSY NEEDLE
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