Visitec Eye Speculum

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843196 ↗

FDA Product Code

HNC

Device Class

Class I

Regulation

21 CFR Part 886.4350

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Visitec Ophthalmic Aspiration Unit Model 100

  Class II

  FDA 510(k) K853961 Active Cleared 13 Dec 1985

• Visi-Wipe

  Class I

  FDA 510(k) K884924 Active Cleared 31 Jan 1989

• Micro Surgical Handle

  Class I

  FDA 510(k) K831996 Active Cleared 12 Jul 1983

• Visitec Canalicular Stent

  Unclassified

  FDA 510(k) K915809 Active Cleared 24 Feb 1992

• Visitec Collar Button Catheter {griffiths}

  Unclassified

  FDA 510(k) K953394 Active Cleared 12 Oct 1995

• Visi-Sorb Absorbant Stick

  Class II

  FDA 510(k) K900786 Active Cleared 18 May 1990

See all devices from Visitec Co. →