Cleared Traditional

K954596 - PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM

K954596 is an FDA 510(k) clearance for PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM, manufactured by Promedical , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K954596 · Promedical , Ltd. · Gastroenterology & Urology device
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Oct 1995
Decision
4d
Days
Class 2
Risk

K954596 is an FDA 510(k) clearance for the PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Promedical , Ltd. (Wyckoff, US). The FDA issued a Cleared decision on October 7, 1995 after a review of 4 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 Promedical , Ltd. devices

FDA 510(k) Submission Details - K954596

510(k) Number K954596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1995
Decision Date October 07, 1995
Days to Decision 4 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
126d faster than avg
Panel avg: 130d · This submission: 4d
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 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K954596.
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
K961897 · Wilson-Cook Medical, Inc. · Jan 1997
DAUM BIOPSYNEEDLE
K961185 · Ferguson Medical · Apr 1996
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K943304 · Olympus America, Inc. · Dec 1995
RUTNER BIOPSY DEVICE
K950810 · Cook Urological, Inc. · Mar 1995
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
WILSON-COOK GI ASPIRATION NEEDLE
K934356 · Wilson-Cook Medical, Inc. · Jan 1994