510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812105Substantially Equivalent

Anogo Disposable Shoe Cover

Anago, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812105 is the FDA 510(k) clearance record for ANOGO DISPOSABLE SHOE COVER, a class I device, cleared for Anago, Inc. on under FDA product code BWP (Shoe And Shoe Cover, Conductive). FDA records list 5 510(k) clearances for Anago, Inc., from to . As of , FDA records show no recalls naming K812105.

Clearance record

Decision date
Received
(49 days to decision)
Product code
BWP Shoe And Shoe Cover, Conductive
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Anago, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BWP

Trailing 12 months

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

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