510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962604Substantially Equivalent

Prosys Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing

Convatec, A Division of E.R. Squibb & Sons, Skillman NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962604 is the FDA 510(k) clearance record for PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING, a class I device, cleared for Convatec, A Division of E.R. Squibb & Sons on under FDA product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile). FDA records list 84 510(k) clearances for Convatec, A Division of E.R. Squibb & Sons, from to . As of , FDA records show no recalls naming K962604.

Clearance record

Decision date
Received
(16 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
Convatec, A Division of E.R. Squibb & Sons 100 Headquarters Park Dr., Skillman NJ
510(k) summary
Summary
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