510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945813Substantially Equivalent

Becton Dickinson Precision Cut(tm) Coaxial Introducer Needle with Depth Stop

BD Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945813 is the FDA 510(k) clearance record for BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code FCG (Biopsy Needle). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K945813.

Clearance record

Decision date
Received
(71 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
510(k) summary
Summary
Third party review
No

Clearances, product code FCG

Trailing 12 months

FDA records hold no clearances under product code FCG in the trailing twelve months.

FDA records show no clearances under product code FCG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260