Disposable Turp Fluid Containment Drape - Sterile

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

510(k) Number

K922100 ↗

FDA Product Code

EJJ

Device Class

Class II

Regulation

21 CFR Part 872.3070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Disposable Turp Fluid Containment Drape - Sterile

  Class II

  FDA 510(k) K913448 Active Cleared 7 Feb 1992

• Drape, Surgical - Utility Drape - Sterile

  Class II

  FDA 510(k) K903726 Active Cleared 27 Aug 1990

• Stopcock

  Class II

  FDA 510(k) K913560 Active Cleared 31 Dec 1991

• Disposable Cystoscopy Splash Drape-Sterile #599

  Class II

  FDA 510(k) K913447 Active Cleared 7 Feb 1992

• Sterilization Wraps #620, 624, 648, 640, 636, 630, 612

  Class II

  FDA 510(k) K863981 Active Cleared 25 Nov 1986

• Sterile Field #605 Fenestrated Sterile Field #606

  Class II

  FDA 510(k) K864111 Active Cleared 30 Oct 1986

See all devices from Graham Medical Products →

• What is the purpose of the Disposable Turp Fluid Containment Drape?

  The drape is designed to contain fluid and prevent spills during Transurethral Resection of the Prostate (TURP) procedures.

• Is the Disposable Turp Fluid Containment Drape sterile?

  Yes, the device is supplied sterile and is intended for single-use.

• What is the regulatory classification of the device?

  The device is classified as a Class 2 device and is regulated under the regulation number 872.3070.

• Who is the manufacturer of the device?

  The device is manufactured by Graham Medical Products.