510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190306Substantially Equivalent

AMD Ritmed AssureWear VersaGown

AMD Medicom Inc., Pointe-Claire, Montreal, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190306 is the FDA 510(k) clearance record for AMD Ritmed AssureWear VersaGown, a class II device, cleared for Amd Medicom, Inc. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 2 510(k) clearances for Amd Medicom, Inc., from to . As of , FDA records show no recalls naming K190306.

Clearance record

Decision date
Received
(339 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Amd Medicom, Inc. 2555 Chemin De L'Aviation, Pointe-Claire, Montreal, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYC

Trailing 12 months

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

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