Oval Cup Biopsy Forcep(23/5) Used W/Colonoscope

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

510(k) Number

K874013 ↗

FDA Product Code

OCZ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Oval Cup Biopsy Forcep

  Class II

  FDA 510(k) K911155 Active Cleared 7 Aug 1991

• Cleaning Brush

  Class I

  FDA 510(k) K874239 Active Cleared 29 Dec 1987

• Guide Wire

  Class I

  FDA 510(k) K874164 Active Cleared 7 Dec 1987

• Sheath, Endoscope

  Class II

  FDA 510(k) K862059 Active Cleared 4 Nov 1986

• Polypectomy Snare

  Class II

  FDA 510(k) K862060 Active Cleared 27 Jun 1986

• Endoscopic Retrograde Cholangiopancreatography

  Class II

  FDA 510(k) K860990 Active Cleared 13 May 1986

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• What is the Oval Cup Biopsy Forcep (23/5) used for?

  The Oval Cup Biopsy Forcep (23/5) is an endoscopic grasping/cutting instrument designed for biopsy procedures. It is specifically used with a colonoscope for tissue sampling during gastrointestinal examinations in gastroenterology and urology procedures.

• Is the Oval Cup Biopsy Forcep reusable or single-use?

  The Oval Cup Biopsy Forcep (23/5) is supplied as a single-use instrument and is not intended for reuse. This design ensures sterility for each procedure and eliminates the need for cleaning and sterilization between uses.

• What is the regulatory classification of this device?

  The Oval Cup Biopsy Forcep (23/5) is authorized under FDA 510K clearance with product code OCZ and is classified as a Class II medical device. It is substantially equivalent to predicate devices for use in gastroenterology and urology procedures.

• Is the Oval Cup Biopsy Forcep MRI compatible?

  No, the Oval Cup Biopsy Forcep (23/5) is not MRI compatible. It is designed specifically for use with colonoscopes during gastrointestinal examinations and should not be used in MRI environments.