Stick Sponge, Strung Tonsil Sponge Double Strung

• • Terminated Z-1763-2016 FDA Class II ·initiated 31 Mar 2016

  Product packaging defective compromising sterility

510(k) Number

K872806 ↗

FDA Product Code

EFQ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Gauze Cherry Sponge

  Class I

  FDA 510(k) K872809 Active Cleared 4 Aug 1987

• Strung Telfa Non-Adherent Sponge

  Class II

  FDA 510(k) K904514 Active Cleared 27 Mar 1991

• Non-Woven Tracheotomy Sponge

  Class I

  FDA 510(k) K872807 Active Cleared 4 Aug 1987

• Suction Tube Tip Fits Over Bussie Frazier Tube

  Class I

  FDA 510(k) K872906 Active Cleared 11 Aug 1987

• Strung Dental Rolls

  Class I

  FDA 510(k) K872810 Active Cleared 4 Dec 1987

• Cotton Neurological Sponge

  Class II

  FDA 510(k) K854713 Active Cleared 20 Mar 1986

See all devices from American Silk Sutures, Inc. →