Becton Dickinson Precision Cut Coaxial Introducer Needle With Depth Stop

No FDA recalls found in the data synced 22 Oct 2026.

Full name

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

510(k) Number

K945813 ↗

FDA Product Code

FCG

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the Becton Dickinson Precision Cut Coaxial Introducer Needle With Depth Stop used for?

  This device is a coaxial introducer needle designed for use in biopsy procedures, specifically indicated for gastroenterology and urology applications as noted in the advisory committee review, allowing precise tissue sampling during diagnostic interventions.

• Is the Becton Dickinson Precision Cut Coaxial Introducer Needle With Depth Stop sterile and single-use?

  Yes, the device is supplied sterile and intended for single-use only, as stated in the device description, to ensure patient safety and prevent cross-contamination during biopsy procedures.

• What regulatory pathway was used for the Becton Dickinson Precision Cut Coaxial Introducer Needle With Depth Stop?

  The device received FDA 510(k) clearance through the traditional pathway, being found substantially equivalent to a predicate device, with clearance number K945813 granted on February 7, 1995.

• Who manufactures the Becton Dickinson Precision Cut Coaxial Introducer Needle With Depth Stop and where is it made?

  The device is manufactured by Becton Dickinson Vacutainer Systems Preanalytic, located at 1 Becton Dr., Franklin Lakes, New Jersey 07417, United States, as specified in the device data.