Cleared Traditional

K960509 - 18 GAUGE TRU-CUT BIOPSY NEEDLE

K960509 is an FDA 510(k) clearance for 18 GAUGE TRU-CUT BIOPSY NEEDLE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 59-day FDA review.

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

FDA 510(k) Submission Details - K960509

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
72d faster than avg
Panel avg: 131d · This submission: 59d
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 297
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K960509.
TEMNO ACHIEVE BIOPSY NEEDLE
K960064 · Bauer Medical, Inc. · Apr 1996
TEMNO DOUBLE SHOT BIOPSY NEEDLE
K960065 · Bauer Medical, Inc. · Apr 1996
LILY MULTICANNULA GUIDE
K954999 · Lily Imaging Solutions Co. · Apr 1996
AUTOMATED TRU-CUT BIOPSY DEVICE
K954529 · Baxter Healthcare Corp · Dec 1995
TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE
K954265 · Promex, Inc. · Sep 1995
URESIL INTRODUCING NEEDLE
K953923 · Uresil Corp. · Sep 1995