Sterile Gauze Product Line

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K941455 ↗

FDA Product Code

EFQ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESK Substantially Equivalent — Kit

• Labor and Delivery Tray

  Class II

  FDA 510(k) K936120 Active Cleared 30 Mar 1994

• O.R. Basin Set Tray

  Class II

  FDA 510(k) K935741 Active Cleared 15 Feb 1994

• Incision/Drainage Tray

  Class II

  FDA 510(k) K935681 Active Cleared 10 Feb 1994

• C-Section Tray

  Class II

  FDA 510(k) K940518 Active Cleared 18 Aug 1994

• Dental Tray

  Class I

  FDA 510(k) K941349 Active Cleared 26 Jul 1994

• Skin Scrub Tray

  Class II

  FDA 510(k) K935742 Active Cleared 10 Feb 1994

See all devices from Cush Medical Products →