Surgical Procedure Tray/Laparoscopy Cholecystectom

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

510(k) Number

K905459 ↗

FDA Product Code

LRO

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

• 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

• Angio Sys Sterile Field Cover

  Not classified

  FDA 510(k) K843257 Active Cleared 21 Sep 1984

See all devices from Angiosystems, Inc. →

• What is the Surgical Procedure Tray for Laparoscopy Cholecystectomy used for?

  It is a pre-assembled set of instruments and supplies intended for use in laparoscopic gallbladder removal procedures, designed to support the surgical team by providing necessary tools in a sterile, ready-to-use configuration during the operation.

• How is the Surgical Procedure Tray supplied and is it reusable?

  The tray is supplied as a sterile, single-use device and is intended for one-time use only in the operating room setting; no reusability is indicated in the provided data, so it should be discarded after each procedure.

• What regulatory clearance does the Surgical Procedure Tray have and what does it mean?

  The device has FDA 510(k) clearance under K905459, meaning it was determined to be substantially equivalent to a predicate device under product code LRO, which allows it to be legally marketed for its intended use.