On the Spot Candidasure

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K883118 ↗

FDA Product Code

LRF

Device Class

Class II

Regulation

21 CFR Part 866.3165

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Hypodermic Needles & Syringes

  Class I

  FDA 510(k) K821348 Active Cleared 10 Jun 1982

• Medi-Tech Dilatation Catheters

  Class II

  FDA 510(k) K843383 Active Cleared 24 Oct 1984

• Catheter, External Male Nursing Care

  Class II

  FDA 510(k) K781780 Active Cleared 7 Dec 1978

• Catheter, Transluminal Balloon

  Class I

  FDA 510(k) K781772 Active Cleared 6 Mar 1979

• Enter-A1 Enteric Feeding Tube

  Class II

  FDA 510(k) K812279 Active Cleared 25 Aug 1981

• Coagulation Reference Plasma, Abnormal

  Class II

  FDA 510(k) K904073 Active Cleared 22 Oct 1990

See all devices from Medi-Tech, Inc. →