Cleared Traditional

K945813 - BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP

K945813 is an FDA 510(k) clearance for BECTON DICKINSON PRECISION CUT(TM) COAX..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K945813 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
71d
Days
Class 2
Risk

K945813 is an FDA 510(k) clearance for the BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 71 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K945813

510(k) Number K945813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date February 07, 1995
Days to Decision 71 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
60d faster than avg
Panel avg: 131d · This submission: 71d
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 92
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K945813.
B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
K950982 · B. Braun of America, Inc. · Apr 1995
RUTNER BIOPSY DEVICE
K950810 · Cook Urological, Inc. · Mar 1995
GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA
K935844 · Medi-Globe Corp. · Feb 1995
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K945146 · Promex, Inc. · Dec 1994
WILSON-COOK GI ASPIRATION NEEDLE
K934356 · Wilson-Cook Medical, Inc. · Jan 1994
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · C.R. Bard, Inc. · Jun 1991