Brimfield Precision Grasper/Dissector

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

510(k) Number

K946263 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Brimfield Precision Scissor

  Class II

  FDA 510(k) K933388 Active Cleared 21 Oct 1993

• Brimfield Precision Detachable Scissor

  Class II

  FDA 510(k) K952785 Active Cleared 26 Jul 1995

• Brimfield Precision Articulating Fan Retractor

  Class II

  FDA 510(k) K953410 Active Cleared 29 Sep 1995

• Brimfield Precision Grasper/Dissector

  Class II

  FDA 510(k) K933387 Active Cleared 15 Oct 1993

• Insulated Surgical Electrode

  Class II

  FDA 510(k) K942499 Active Cleared 1 Jul 1994

• Brimfield Precision Second Generation Grasper/Dissector

  Class II

  FDA 510(k) K941276 Active Cleared 29 Apr 1994

See all devices from Springfield Surgical Instruments →

• What is the Brimfield Precision Grasper/Dissector used for?

  The Brimfield Precision Grasper/Dissector is designed for laparoscopic and endoscopic procedures in general and plastic surgery, as well as specialized applications in gastroenterology and urology. Its ergonomic design and sharp, atraumatic tips allow surgeons to grasp, hold, and dissect soft tissues and vascular structures with precision, minimizing trauma to surrounding areas during minimally invasive surgery.

• Is the Brimfield Precision Grasper/Dissector intended for single-use or reuse?

  This device is explicitly intended for single-use only. It is supplied sterile and packaged for one-time use, ensuring compliance with best practices for infection control and sterility in surgical settings. Reuse is not recommended or supported by the manufacturer.

• How should the Brimfield Precision Grasper/Dissector be stored to maintain sterility?

  Storage must follow the manufacturer’s guidelines to preserve sterility. The device is packaged sterile for single-use, so it should remain unopened until immediately before use. Once opened, it should be used promptly and disposed of appropriately. Avoid exposure to moisture, heat, or contamination during storage.

• Does this device have any reusable components, and if so, how should they be reprocessed?

  The provided device data does not specify reusable components for the Brimfield Precision Grasper/Dissector. As it is designed for single-use, no reprocessing protocols apply. If future models or variations include reusable parts, those would require validated reprocessing protocols to ensure safety and sterility, but this is not applicable to the current single-use version.

• What regulatory clearance does the Brimfield Precision Grasper/Dissector hold?

  The device holds FDA 510(k) clearance under the classification code GCJ and regulation 876.1500, with a Substantially Equivalent (SESE) determination. The clearance number is K946263, and it was granted following review by the Surgical Devices Panel (SU) of the Gastroenterology and Urology advisory committees. No additional regulatory markings beyond this clearance are referenced.