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FXY — Hood, Surgical Class II

FDA Device Classification

Classification Details

Product Code
FXY
Device Class
Class II
Regulation Number
878.4040
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222214thi total healthcare innovationViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)October 17, 2023
K200493stryker corporationStryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 SurgiMarch 21, 2020
K140588stryker corporationFLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSJune 26, 2014
K904969chicago assoc. for retarded citizensHOOD, OPERATING, SURGICALDecember 12, 1990
K904276anagoDISPOSABLE BEARD COVERNovember 21, 1990
K903533biomedical devicesSTERI-SHIELDOctober 19, 1990
K902677biomedical devicesSTERI-SHIELDAugust 17, 1990
K880431james riverCARETEX SURGEON'S HOODSFebruary 24, 1988
K770261sherwood medical industriesHOOD, CLARION SURGEONSMarch 1, 1977
K770257sherwood medical industriesHOOD & BEARD COVER, CLARION SURGEON'SFebruary 25, 1977
K761070owenbyP.S.M. SURGICAL HOODDecember 30, 1976
K760855surgikosBARRIER SURGICAL HOODNovember 3, 1976
K760865surgikosBARRIER FASHION BONNETNovember 3, 1976