Biopsy Device Accessory

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K944252 ↗

FDA Product Code

FCK

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Biopsy Device Accessory

  Class II

  FDA 510(k) K951326 Active Cleared 15 May 1995

• Retractor Arm Clamp

  Class I

  FDA 510(k) K960019 Active Cleared 9 Feb 1996

• Micromark Clip

  Class II

  FDA 510(k) K970817 Active Cleared 11 Sep 1997

• Surgical Staple Marker Device (Modify)

  Class II

  FDA 510(k) K963015 Active Cleared 7 Oct 1996

• Modified Biopsy Needle

  Class II

  FDA 510(k) K951229 Active Cleared 6 Apr 1995

• Mammotome Biopsy Probe and Housing (Mammotome)

  Class II

  FDA 510(k) K970565 Active Cleared 28 Mar 1997

See all devices from Biopsys Medical, Inc. →

• What is the Biopsy Device Accessory used for?

  The Biopsy Device Accessory is an instrument used in biopsy procedures involving suction, as classified under regulation number 876.1075. It is intended for use in the medical specialties of gastroenterology and urology to assist in obtaining tissue samples via suction-assisted biopsy techniques.

• How is the Biopsy Device Accessory supplied and is it sterile or reusable?

  The device data does not specify whether the Biopsy Device Accessory is supplied sterile, single-use, or reusable. Information about its supply format, sterility status, or reuse instructions is not included in the provided authorization or specifications details.

• What regulatory pathway was used for the Biopsy Device Accessory?

  The Biopsy Device Accessory received FDA 510(k) clearance under K944252 on December 5, 1994, through a traditional review process. It was determined to be substantially equivalent to a predicate device, which is the regulatory pathway for moderate-risk Class II devices like this one.