510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901219Substantially Equivalent

External Leg Bag

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

K901219 is the FDA 510(k) clearance record for EXTERNAL LEG BAG, a class I device, cleared for Orion Life Systems, Inc. on under FDA product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile). FDA records list 33 510(k) clearances for Orion Life Systems, Inc., from to . As of , FDA records show no recalls naming K901219.

Clearance record

Decision date
Received
(106 days to decision)
Product code
FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Orion Life Systems, Inc. 124 Messner Dr., Wheeling IL
Third party review
No

Clearances, product code FAQ

Trailing 12 months

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

FDA records show no clearances under product code FAQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAQ, 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