510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955609Substantially Equivalent

Conveen Urine Bag - Sterile

MEDLINE INDUSTRIES, LP - Northfield, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955609 is the FDA 510(k) clearance record for CONVEEN URINE BAG - STERILE, a class I device, cleared for Coloplast Corp. on under FDA product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K955609.

Clearance record

Decision date
Received
(21 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
Coloplast Corp. 1955 W. Oak Cir., Marietta GA
510(k) summary
Statement
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