Cleared Traditional

18 GAUGE TRU-CUT BIOPSY NEEDLE (K960509) - FDA 510(k) Clearance

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

K960509 · Baxter Healthcare Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
59d
Days
Class 2
Risk

K960509 is an FDA 510(k) clearance for the 18 GAUGE TRU-CUT BIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 59 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K960509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date April 04, 1996
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
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 93
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K960509.
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
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
BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.
K922939 · C.R. Bard, Inc. · Feb 1993