Wgl Endoscopic Grasper W/Detachable Strap

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

510(k) Number

K954649 ↗

FDA Product Code

GCJ

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 Wilson Greatbatch Technologies, Inc. →

• What types of procedures is this endoscopic grasper designed to assist with, and how does the detachable strap improve its functionality?

  The WGL Endoscopic Grasper with Detachable Strap is designed for use in endoscopic procedures, helping surgeons grasp and manipulate tissue or objects within body cavities, hollow organs, or canals. The detachable strap enhances versatility by allowing adjustments during procedures, enabling better control and adaptability in tight or complex spaces.

• Is this device intended for single-use or reusable applications, and what does that mean for maintenance?

  This device is explicitly supplied as a reusable instrument, meaning it is engineered for repeated use after proper cleaning, sterilization, and maintenance. Reusability requires adherence to strict protocols to ensure safety and functionality between procedures.

• How is the regulatory status of this device determined, and what does the FDA clearance under product code GCJ indicate?

  The WGL Endoscopic Grasper received FDA clearance through a 510(k) submission, classified under product code GCJ (Gastroenterology and Urology). The clearance is based on a determination of substantial equivalence to a predicate device, meaning it is deemed as safe and effective as a comparable device already on the market.

• What advisory committees were involved in reviewing this device, and how does that relate to its intended use?

  The device was reviewed by the Gastroenterology and Urology advisory committees, which aligns with its classification under product code GCJ. These committees provide expert input on endoscopic accessories, ensuring the device meets standards for use in gastrointestinal and urological endoscopic procedures.