Cleared Traditional

K961185 - DAUM BIOPSYNEEDLE

K961185 is the FDA 510(k) clearance for DAUM BIOPSYNEEDLE by Ferguson Medical. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K961185 · Ferguson Medical · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 1996
Decision
35d
Days
Class 2
Risk

K961185 is an FDA 510(k) clearance for the DAUM BIOPSYNEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on April 30, 1996 after a review of 35 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 Ferguson Medical devices

Submission Details

510(k) Number K961185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1996
Decision Date April 30, 1996
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K961185.
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K970563 · Olympus America, Inc. · Apr 1997
SMARTGUIDE
K963894 · Ferguson Medical · Mar 1997
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
K961897 · Wilson-Cook Medical, Inc. · Jan 1997
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