Mic Low Profile Gastrostomy Tube

• • Ongoing Z-2422-2024 FDA Class II ·initiated 31 May 2024

  The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

510(k) Number

K922667 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

• Mic Percutaneous Endoscopic Gastrostomy Tube

  Class II

  FDA 510(k) K900464 Active Cleared 5 Dec 1990

• Norfolk/Norwich Pressure Infusion Box

  Class I

  FDA 510(k) K810954 Active Cleared 21 Apr 1981

• Mic Gastro-Enterostomy Tube Modification Open recall

  Class II

  FDA 510(k) K921370 Active Cleared 2 May 1994

• MIC (Specific Line) Insertion Kit

  Class II

  FDA 510(k) K875126 Active Cleared 2 Mar 1988

• Mic Transgastric Jejunal Feeding Tube Kit

  Class II

  FDA 510(k) K921652 Active Cleared 2 May 1994

• Mic Jejunal Feeding Tube

  Class II

  FDA 510(k) K853197 Active Cleared 22 Aug 1985

See all devices from Medical Innovations Corp. →