Cleared Traditional

K902319 - BAUER TEMNO BIOPSY NEEDLE

K902319 is an FDA 510(k) clearance for BAUER TEMNO BIOPSY NEEDLE, manufactured by Proact, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K902319 · Proact, Ltd. · Gastroenterology & Urology device
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Sep 1990
Decision
106d
Days
Class 2
Risk

K902319 is an FDA 510(k) clearance for the BAUER TEMNO BIOPSY NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Proact, Ltd. (State College, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 106 days - within the typical 510(k) review window.

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.

View all Proact, Ltd. devices

FDA 510(k) Submission Details - K902319

510(k) Number K902319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1990
Decision Date September 06, 1990
Days to Decision 106 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 130d · This submission: 106d
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 K902319.
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
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · C.R. Bard, Inc. · Jun 1991
MANAN PROSTATIC BIOPSY NEEDLE
K895897 · Manan Medical Products, Inc. · Oct 1989
BIOPSY NEEDLE GUIDE ATTACHMENT
K890327 · Elscint, Inc. · Mar 1989
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
K882549 · Acuson Corp. · Jul 1988