Instruments Nonsterile & Sterile

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802726 ↗

FDA Product Code

HAO

Device Class

Class I

Regulation

21 CFR Part 882.4535

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Various Instruments & Instrument Trays

  Class I

  FDA 510(k) K830219 Active Cleared 12 Apr 1983

• Sterile Disposable Instrument Trays

  Class I

  FDA 510(k) K810004 Active Cleared 26 Jan 1981

• G.E.V. Disposable Scalpels

  Class I

  FDA 510(k) K822893 Active Cleared 22 Oct 1982

• I.V. Start Set

  Class I

  FDA 510(k) K791885 Active Cleared 22 Oct 1979

• Central Venous Catheter Dressing Tray

  Class I

  FDA 510(k) K791887 Active Cleared 17 Oct 1979

• I.V. Care Kit

  Class I

  FDA 510(k) K791886 Active Cleared 26 Oct 1979

See all devices from Ascep, Inc. →