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510(k) K904801

ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE by Orion Life Systems, Inc. — Product Code KGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1991
Date Received
October 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Orion Life Systems, Inc.

  • K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID (January 24, 1995)
  • K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943834 — STERILE .9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943832 — STERILE .9% SODIUM CHLORIDE FOR IRRATION (November 21, 1994)
  • K943836 — PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943829 — PRE-FILLED SYSRINGE W/STERILE WATER (November 21, 1994)
  • K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943828 — STERILE WATER FOR IRRIGATION (November 21, 1994)
  • K943833 — STERILE WATER FOR IRRATION (November 1, 1994)
  • K923168 — DUAL PORT ENTERAL Y-ADAPTOR (June 17, 1994)

Other clearances for product code KGC

  • K242211 — PUMA-G Pediatric System (April 29, 2025)
  • K223916 — PUMA-G System (March 29, 2023)
  • K193612 — AMT Suture Delivery System (March 12, 2020)
  • K191844 — Fidmi Low Profile Enteral Feeding Device (September 30, 2019)
  • K182832 — Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (June 26, 2019)
  • K183057 — PUMA-G System (April 10, 2019)
  • K170323 — Entuit Start Initial Placement Gastrostomy Set (September 14, 2017)
  • K120587 — AMT T-FASTENER ANCHOR KIT (May 25, 2012)
  • K093312 — KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL A (December 8, 2009)
  • K073718 — MEDLINE GASTROSTOMY TUBE (March 19, 2008)