Cleared Traditional

K954231 - AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT

K954231 is an FDA 510(k) clearance for AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTR..., manufactured by Promex, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K954231 · Promex, Inc. · Gastroenterology & Urology device
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Sep 1995
Decision
11d
Days
Class 2
Risk

K954231 is an FDA 510(k) clearance for the AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 22, 1995 after a review of 11 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Promex, Inc. devices

FDA 510(k) Submission Details - K954231

510(k) Number K954231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1995
Decision Date September 22, 1995
Days to Decision 11 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
120d faster than avg
Panel avg: 131d · This submission: 11d
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 92
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K954231.
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
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
RUTNER BIOPSY DEVICE
K950810 · Cook Urological, Inc. · Mar 1995