Gastro-Enterostomy Tube

• • Terminated Z-0938-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011

  The product is misbranded, i.e. the Gastric (center) port may be mislabeled as the Jejunal port, and the Jejunal (side) port mislabeled as the Gastric port.

510(k) Number

K852707 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 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

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