Cleared Traditional

K861959 - BMRI SOFT TISSUE BIOPSY NEEDLE

K861959 is an FDA 510(k) clearance for BMRI SOFT TISSUE BIOPSY NEEDLE, manufactured by Bio-Medical Resources, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K861959 · Bio-Medical Resources, Inc. · Gastroenterology & Urology device
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Sep 1986
Decision
126d
Days
Class 2
Risk

K861959 is an FDA 510(k) clearance for the BMRI SOFT TISSUE BIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Bio-Medical Resources, Inc. (St. Louis County, US). The FDA issued a Cleared decision on September 23, 1986 after a review of 126 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 Bio-Medical Resources, Inc. devices

FDA 510(k) Submission Details - K861959

510(k) Number K861959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1986
Decision Date September 23, 1986
Days to Decision 126 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
4d faster than avg
Panel avg: 130d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
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 - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K861959.
PROSTATIC ASPIRATION BIOPSY SET
K870735 · Van-Tec, Inc. · Mar 1987
TEFLON BIOPSY CATHETER W/TIP ANGLE
K870734 · Van-Tec, Inc. · Mar 1987
MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT
K864329 · Dlp, Inc. · Dec 1986
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · Travenol Laboratories, S.A. · Feb 1986
MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY
K854291 · Medsurg Industries, Inc. · Nov 1985
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM
K854297 · Medsurg Industries, Inc. · Nov 1985