Modified Biopsy Needle

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

510(k) Number

K951229 ↗

FDA Product Code

KNW

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

• Mammotome Biopsy Probe and Housing (Mammotome)

  Class II

  FDA 510(k) K970565 Active Cleared 28 Mar 1997

• Biopsy Needle and Housing

  Class II

  FDA 510(k) K942639 Active Cleared 7 Jul 1994

See all devices from Biopsys Medical, Inc. →

• What is the Modified Biopsy Needle used for?

  The Modified Biopsy Needle is designed to remove tissue specimens via cutting or aspiration for microscopic examination in gastroenterology and urology procedures. It facilitates controlled sampling to aid in pathological analysis of gastrointestinal or urological tissues.

• Is the Modified Biopsy Needle supplied as a single-use or reusable instrument?

  The Modified Biopsy Needle is supplied as a reusable medical instrument. It is designed for multiple uses in clinical settings where tissue sampling is required, though proper cleaning and sterilization protocols should be followed between uses.

• What regulatory approvals does the Modified Biopsy Needle have?

  The Modified Biopsy Needle has received FDA 510(k) clearance under the Traditional pathway with a decision date of April 6, 1995. It was reviewed by the Gastroenterology and Urology (GU) Advisory Committee and is classified under product code KNW.

• What sizes and models of the Modified Biopsy Needle are available?

  The device data does not specify available sizes or models of the Modified Biopsy Needle. For specific size options or model variations, please contact the manufacturer Biopsys Medical, Inc. directly or refer to their product documentation.