510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904801Substantially Equivalent

Orion Life Systems Replacement Gastrostomy Tube

Orion Life Systems, Inc., Wheeling IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904801 is the FDA 510(k) clearance record for ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE, a class II device, cleared for Orion Life Systems, Inc. on under FDA product code KGC (Tube, Gastro-Enterostomy). FDA records list 33 510(k) clearances for Orion Life Systems, Inc., from to . As of , FDA records show no recalls naming K904801.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KGC Tube, Gastro-Enterostomy
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Orion Life Systems, Inc. 124 Messner Dr., Wheeling IL
Third party review
No

Clearances, product code KGC

Trailing 12 months

FDA records hold no clearances under product code KGC in the trailing twelve months.

FDA records show no clearances under product code KGC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260