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510(k) K900464

MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE by Medical Innovations Corp. — Product Code KNT

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
December 5, 1990
Date Received
January 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Medical Innovations Corp.

  • K945612 — MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE (April 19, 1995)
  • K940548 — MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE (February 22, 1995)
  • K943685 — MIC DISPOSABLE SNARE (November 1, 1994)
  • K926581 — MIC TRANSGASTRIC JEJUNAL TUBE (September 28, 1994)
  • K921652 — MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT (May 2, 1994)
  • K921370 — MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION (May 2, 1994)
  • K924065 — MIC PEG TUBE (February 17, 1994)
  • K922667 — MIC LOW PROFILE GASTROSTOMY TUBE (December 1, 1993)
  • K913320 — MIL CM-II COAGULATION MACHINE (June 16, 1992)
  • K903531 — ANTICARDIOLIPIN ANTIBODY TEST SYSTEM (January 25, 1991)

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  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)