Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges

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

510(k) Number

K981219 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Bipolar Scissors

  Class II

  FDA 510(k) K972558 Active Cleared 7 Oct 1997

• Bipolar Coagulation System

  Class II

  FDA 510(k) K010112 Active Cleared 2 Apr 2001

• Enable Endoscopic Bipolar Scissors

  Class II

  FDA 510(k) K992996 Active Cleared 24 Nov 1999

• Are the Oscar Bipolar Scissors and cartridges designed for single-use or reusable applications in surgery?

  The Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges are explicitly labeled for reusable use in open surgical procedures. The cartridges themselves are designed to be replaced and reused, while the scissors are the durable, reusable component of the system. This setup allows for cost-effective use across multiple procedures, provided proper cleaning and maintenance are followed.

• What types of surgical procedures are these devices primarily intended for?

  The Oscar Bipolar Scissors and cartridges are substantially equivalent to predicate devices classified under FDA product code GEI, which falls under the General and Plastic Surgery advisory committee category. While this does not specify exact indications, the design suggests they are suited for open surgical procedures where precise cutting and controlled hemostasis are required, such as in general or plastic surgery settings.

• How are the Oscar Bipolar Scissors and cartridges supplied, and what should I consider for storage?

  The data does not specify packaging details or storage conditions, but as reusable devices, they should be cleaned, disinfected, and sterilized between uses per manufacturer guidelines. Since no sterility information is provided, assume they are not pre-sterilized and require reprocessing. Storage should follow standard surgical instrument protocols to prevent contamination or damage.

• Are there different sizes or models of the Oscar Bipolar Scissors available?

  The provided data does not list specific sizes or models of the Oscar Bipolar Scissors, so exact variations (e.g., blade length, handle design) cannot be confirmed. However, the reusable cartridge system implies flexibility in adapting to different surgical needs, so it’s possible multiple scissor configurations exist. For precise sizing details, refer to the manufacturer’s catalog or technical specifications.

• How was the FDA clearance for these devices determined, and what does that mean for their use?

  The Oscar Bipolar Scissors and cartridges received FDA 510(k) clearance (K981219) in 1998 under the Substantially Equivalent (SESE) determination. This means the device was deemed comparable to a legally marketed predicate (pre-existing) device in terms of technology, performance, and intended use. Clinically, this clearance confirms the device meets regulatory standards for cutting and coagulating tissue during open surgical procedures, but it does not imply any specific clinical superiority or additional indications beyond what was reviewed.