Olympus Bipolar Forceps

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

510(k) Number

K955623 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 3D Surgical Endoscopy System for General Surgery

  Class II

  FDA 510(k) K943307 Active Cleared 20 Dec 1995

• Olympus Fg-45/46-1 Grasping Forceps

  Class II

  FDA 510(k) K955049 Active Cleared 15 Dec 1995

• Olympus Unsaturated Iron Binding Capacity Reagent

  Class I

  FDA 510(k) K955139 Active Cleared 12 Feb 1996

• Olympus Fb Series Biopsy Forceps

  Class II

  FDA 510(k) K962555 Active Cleared 30 Jul 1996

• Olympus Fd-5 Hot Biopsy Forceps

  Class II

  FDA 510(k) K951445 Active Cleared 3 May 1995

• Olympus Biopsy Forceps Model Fb-44

  Class II

  FDA 510(k) K950786 Active Cleared 6 Mar 1995

See all devices from Olympus America, Inc. →

• What is the Olympus Bipolar Forceps designed for in surgical procedures?

  The Olympus Bipolar Forceps is specifically engineered to provide controlled bipolar electrosurgical energy for coagulating and cutting tissue with precision. This design minimizes heat spread to surrounding areas, making it ideal for delicate procedures in plastic surgery and general surgery where reducing collateral damage is critical.

• Are Olympus Bipolar Forceps intended for single-use or reusable applications?

  The Olympus Bipolar Forceps are designed for reusable applications in sterile surgical settings. While some similar devices may be disposable, this model follows traditional reuse practices, requiring adherence to manufacturer guidelines for sterilization and maintenance to ensure functionality and safety.

• What regulatory clearance does the Olympus Bipolar Forceps hold?

  The Olympus Bipolar Forceps holds FDA clearance under a 510(k) submission (K955623), determined to be substantially equivalent to a predicate device. This clearance is specific to its classification as a Bipolar Electrosurgical Forceps (Product Code: GEI) and does not include explicit MRI safety labeling.

• How should Olympus Bipolar Forceps be stored to maintain functionality?

  To preserve functionality, Olympus Bipolar Forceps must be stored according to the manufacturer’s guidelines for sterilization and maintenance. Proper storage ensures the device remains effective for reuse and reduces the risk of contamination or damage between procedures.

• What advisory committees were involved in the approval process for this device?

  The Olympus Bipolar Forceps was reviewed by the Surgical and Urological Devices (SU) Advisory Committee during its FDA clearance process. This committee provides expert input on devices intended for general and plastic surgery applications, ensuring the device meets safety and efficacy standards.