Cleared Traditional

TEMNO DOUBLE SHOT BIOPSY NEEDLE (K960065) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960065 · Bauer Medical, Inc. · Gastroenterology & Urology device
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Apr 1996
Decision
91d
Days
Class 2
Risk

K960065 is an FDA 510(k) clearance for the TEMNO DOUBLE SHOT BIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Bauer Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 5, 1996 after a review of 91 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 Bauer Medical, Inc. devices

Submission Details

510(k) Number K960065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1996
Decision Date April 05, 1996
Days to Decision 91 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
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K960065.
SKINNY,FRANSEEN,WESCOTT NEEDLES
K962907 · Baxter Healthcare Corp · Oct 1996
BIOPSY INTRODUCER NEEDLE
K963390 · Baxter Healthcare Corp · Oct 1996
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
K962077 · C.R. Bard, Inc. · Jul 1996
18 GAUGE TRU-CUT BIOPSY NEEDLE
K960509 · Baxter Healthcare Corp · Apr 1996
AUTOMATED TRU-CUT BIOPSY DEVICE
K954529 · Baxter Healthcare Corp · Dec 1995
MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE
K935814 · Boston Scientific Corp · Mar 1994