Barrier C-Arm Drape

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791438 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Edge Protector, Barrier

  Class II

  FDA 510(k) K790306 Active Cleared 22 Feb 1979

• Barrier Pediatric/Incise Drape 450

  Class II

  FDA 510(k) K780839 Active Cleared 14 Aug 1978

• Barrier General Surgery Pack

  Class II

  FDA 510(k) K760807 Active Cleared 3 Nov 1976

• Barrier Antimicrobial Incise Drape

  Class II

  FDA 510(k) K820543 Active Cleared 22 Jul 1982

• Purge Line Unit

  Class II

  FDA 510(k) K790804 Active Cleared 25 May 1979

• Sterile Surgical Scrub Brush

  Class I

  FDA 510(k) K874653 Active Cleared 30 Dec 1987

See all devices from Surgikos, Inc. →

• What is the Barrier C-Arm Drape specifically designed to protect during fluoroscopic procedures?

  The Barrier C-Arm Drape is designed to create a sterile barrier around the surgical site to prevent contamination from the C-arm imaging equipment and the surrounding environment. This helps maintain a clean field while allowing the imaging components to pass through, ensuring sterility is preserved during procedures like orthopedic, vascular, or spinal surgeries.

• Is the Barrier C-Arm Drape sterile when received, and how should it be stored to maintain sterility?

  Yes, the Barrier C-Arm Drape is supplied in a sterile package, but it is classified as a non-sterile drape itself. To maintain sterility, storage must follow the manufacturer’s guidelines, which are not detailed here but typically involve keeping the package intact and protected from moisture, dust, or physical damage until use.

• Can this drape be reused, or is it intended for single-use only?

  The Barrier C-Arm Drape is explicitly labeled as a single-use device. Reuse is not recommended, as it could compromise sterility and increase the risk of contamination during surgical procedures.

• What types of surgical procedures is this drape intended for, and where is it typically used?

  While the drape is classified under product code KKX (surgical drape) and intended for use in operating rooms or procedural suites, its specific clinical indication is to maintain sterility during fluoroscopic procedures involving a C-arm. This includes surgeries like orthopedic, vascular, or spinal procedures where imaging access is required, but the device itself is not described as