Corpak Grasping Forceps OCZ

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

Full name

Corpak Grasping Forceps

510(k) Number

K902949 ↗

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 Corpak Co. →

• What specialties primarily use the Corpak Grasping Forceps OCZ, and how is it intended to function during procedures?

  The Corpak Grasping Forceps OCZ is designed for use in gastroenterology and urology procedures. It is a non-powered endoscopic instrument intended for grasping, holding, and manipulating tissue or foreign objects within the gastrointestinal or urinary tract during minimally invasive endoscopic examinations or interventions. Its primary role is to assist in controlled tissue handling or removal during these specialized procedures.

• Is the Corpak Grasping Forceps OCZ intended for single-use or reusable applications, and what maintenance is required?

  The Corpak Grasping Forceps OCZ is reusable and must be properly sterilized and maintained per the manufacturer’s guidelines to ensure safety and functionality. Since it is intended for use in controlled clinical settings like operating rooms or endoscopy suites, adherence to sterilization protocols is critical to prevent cross-contamination and ensure reliable performance.

• How was the regulatory pathway for the Corpak Grasping Forceps OCZ determined, and what does this mean for its use?

  The device was cleared through the FDA 510(k) pathway under classification 876.1500, with a decision of Substantially Equivalent (SE) to a predicate device. This means the Corpak Grasping Forceps OCZ was evaluated against an existing, legally marketed device of the same type and determined to have the same intended purpose and technological characteristics, ensuring its compliance with FDA standards for endoscopic grasping/cutting instruments.

• What types of procedures or clinical settings is the Corpak Grasping Forceps OCZ intended for, and why?

  The Corpak Grasping Forceps OCZ is intended for use in minimally invasive endoscopic procedures, specifically within the gastrointestinal or urinary tract. Its design supports controlled manipulation of tissue or foreign objects during examinations or interventions in operating rooms or endoscopy suites, where precision and sterility are paramount. The device’s non-powered nature and reusable design make it suitable for repeated use in these controlled clinical environments.