XBO1-824-18/19/20 Biopsy Forceps

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

510(k) Number

K012074 ↗

FDA Product Code

OCZ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from The Olympus Optical Co. →

• What is the Olympus XBO1-824 Biopsy Forceps used for?

  The Olympus XBO1-824 Biopsy Forceps is a non-powered endoscopic instrument designed specifically for collecting tissue samples during endoscopic procedures. It is intended for use in the upper and lower digestive tract, making it suitable for diagnostic biopsies in gastroenterology and urology settings. The forceps combine grasping and cutting functions to safely retrieve tissue while minimizing patient discomfort.

• How is the XBO1-824 Biopsy Forceps supplied and intended for use?

  The XBO1-824 Biopsy Forceps is supplied sterile and is intended for single-use only. This ensures clinical safety and reduces the risk of cross-contamination between patients. After use, the device should be disposed of according to standard medical waste protocols. Its sterile packaging maintains integrity until the first use, adhering to best practices for endoscopic instruments.

• Are there different models or sizes available for the XBO1-824 Biopsy Forceps?

  The XBO1-824 Biopsy Forceps comes in three distinct models: XBO1-824-18, XBO1-824-19, and XBO1-824-20. These variations likely correspond to slight differences in design or functionality, such as jaw length, tip shape, or cutting mechanism, to accommodate specific clinical needs. The exact distinctions between models are not detailed in the specifications but may be relevant for procedures requiring precision or access to particular anatomical sites.

• How should the XBO1-824 Biopsy Forceps be stored to maintain sterility?

  To preserve sterility, the XBO1-824 Biopsy Forceps must be stored in its original, unopened packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. The packaging should remain intact until immediately before use. After opening, the device should be used promptly and disposed of as single-use medical waste. Proper storage ensures the device remains safe for clinical use and complies with sterile instrument protocols.

• What regulatory approval does the XBO1-824 Biopsy Forceps hold, and how does it ensure safety?

  The XBO1-824 Biopsy Forceps holds FDA 510(k) clearance under the classification number 876.1500, indicating it has been determined substantially equivalent to a legally marketed device. This approval process includes rigorous evaluation of design, manufacturing processes, and clinical performance to ensure safety and effectiveness. The device is also regulated under the Gastroenterology and Urology advisory committees, reflecting its intended use in specialized medical procedures.