Biopsy Needle Guide Attachment

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

510(k) Number

K890327 ↗

FDA Product Code

FCG

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102

  Class II

  FDA 510(k) K965044 Active Cleared 16 Jun 1997

• Head and Neck Coil for the Gyrex 2T-Dlx

  Class II

  FDA 510(k) K943320 Active Cleared 29 Nov 1994

• Dynex-44 Diagnostic Ultrasound Imaging

  Class II

  FDA 510(k) K812014 Active Cleared 16 Sep 1981

• Gyrex Privilege

  Class II

  FDA 510(k) K954039 Active Cleared 24 Nov 1995

• 2T Prestige(100-6321-0107)/Privilege(100-6326-0102)/Gyrex V-Ep(100-6327-0101)

  Class II

  FDA 510(k) K972592 Active Cleared 15 Sep 1997

• Ultrasound Equipment Model Sdl-100A

  Not classified

  FDA 510(k) K837084 Active Cleared 28 Apr 1983

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• What is the Biopsy Needle Guide Attachment used for?

  The Biopsy Needle Guide Attachment is designed to guide biopsy needles during medical procedures, assisting in the precise placement of biopsy needles in various medical applications, particularly in gastroenterology and urology procedures.

• How is the Biopsy Needle Guide Attachment supplied?

  The device is supplied by Elscint, Inc. and is classified as a Class II medical device. It is intended for use in medical procedures requiring precise needle guidance.

• What is the regulatory status of the Biopsy Needle Guide Attachment?

  The device received FDA 510(k) clearance with the number K890327 on March 8, 1989, and is regulated under product code FCG. It is substantially equivalent to other devices in its class.

• Is the Biopsy Needle Guide Attachment reusable or single-use?

  The device data does not specify whether the Biopsy Needle Guide Attachment is designed for single-use or reuse. For specific usage instructions, please refer to the manufacturer's documentation or contact Elscint, Inc. directly.