Sterile Disposable Surgical Drape/Abdominal Drape

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

510(k) Number

K905466 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Sterile Disposable Drape/Ophthalmic Surgery

  Class II

  FDA 510(k) K905460 Active Cleared 6 Feb 1991

• Angiosys Femoral Angiography Drape

  Class II

  FDA 510(k) K843260 Active Cleared 21 Sep 1984

• Surgical Procedure Tray/Laparoscopy Cholecystectom

  Class II

  FDA 510(k) K905459 Active Cleared 5 Apr 1991

• Angio Sys Brachial Angio Drape

  Not classified

  FDA 510(k) K843258 Active Cleared 21 Sep 1984

• Angio Sys Fluoroscope Drape

  Not classified

  FDA 510(k) K843259 Active Cleared 21 Sep 1984

• Medical Procedure Kits/Arterial Blood Sampling

  Class I

  FDA 510(k) K905464 Active Cleared 31 May 1991

See all devices from Angiosystems, Inc. →

• What is the primary purpose of this surgical drape, and in which types of procedures is it commonly used?

  This sterile disposable surgical drape serves as a protective barrier to isolate the surgical field during procedures, preventing contamination from the patient’s skin, environment, or instruments. It is specifically designed for use in abdominal surgeries, such as laparotomies, where maintaining a sterile operative zone is critical.

• Is this drape intended for reuse, or is it meant to be used only once?

  The drape is explicitly designed for single-use only. It is manufactured sterile and adheres to aseptic techniques, so reuse is not recommended or supported by the manufacturer.

• What are the storage requirements for this product, and why are they important?

  This drape must be stored in a clean, dry area away from direct sunlight and extreme temperatures. Proper storage ensures sterility and prevents degradation of the material, which could compromise its barrier properties during use.

• What are the dimensions of this drape, and how does that affect its application?

  The drape is standardized at 18 inches by [dimension not specified in data, but implied as a typical abdominal drape size], providing sufficient coverage for abdominal surgeries. Its size ensures adequate isolation of the surgical field while maintaining ease of use.

• Can this drape be used in an MRI environment, or are there any compatibility concerns?

  The manufacturer explicitly states that this drape is not MRI-compatible. If MRI imaging is required during or after the procedure, alternative drapes or shielding must be used to avoid interference or safety risks.