510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961319Substantially Equivalent

Epiview

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

K961319 is the FDA 510(k) clearance record for EPIVIEW, cleared for Convatec, A Division of E.R. Squibb & Sons on under FDA product code MGP (Dressing, Wound And Burn, Occlusive). 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 K961319.

Clearance record

Decision date
Received
(94 days to decision)
Product code
MGP Dressing, Wound And Burn, Occlusive
Device class
Unclassified
Review panel
Unknown
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 MGP

Trailing 12 months

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

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