Cleared Traditional

K962905 - TX BIOPSY NEEDLE

K962905 is an FDA 510(k) clearance for TX BIOPSY NEEDLE, manufactured by Gallini S.R.L.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K962905 · Gallini S.R.L. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
78d
Days
Class 2
Risk

K962905 is an FDA 510(k) clearance for the TX BIOPSY NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Gallini S.R.L. (Brooklyn, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 78 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 Gallini S.R.L. devices

FDA 510(k) Submission Details - K962905

510(k) Number K962905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1996
Decision Date October 11, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K962905.
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
DAUM BIOPSYNEEDLE
K961185 · Ferguson Medical · Apr 1996
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K943304 · Olympus America, Inc. · Dec 1995
RUTNER BIOPSY DEVICE
K950810 · Cook Urological, Inc. · Mar 1995