510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961342Substantially Equivalent

Shoe Cover, Non-Sterile

Copioumed Intl., Inc., Green Valley AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961342 is the FDA 510(k) clearance record for SHOE COVER, NON-STERILE, a class I device, cleared for Copioumed Intl., Inc. on under FDA product code FXP (Cover, Shoe, Operating-Room). FDA records list 8 510(k) clearances for Copioumed Intl., Inc., from to . As of , FDA records show no recalls naming K961342.

Clearance record

Decision date
Received
(285 days to decision)
Product code
FXP Cover, Shoe, Operating-Room
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Copioumed Intl., Inc. 19001 S. Richfield # 185, Green Valley AZ
510(k) summary
Statement
Third party review
No

Clearances, product code FXP

Trailing 12 months

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

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