Various Instruments & Instrument Trays

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K830219 ↗

FDA Product Code

FSM

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 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

• Catheter Care Kit Reorder 7940&7941

  Unclassified

  FDA 510(k) K791888 Active Cleared 17 Oct 1979

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