FDA.reportPublic FDA data

510(k) K222214

Device
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
Applicant
Thi Total Healthcare Innovation GmbH
510(k) number
K222214
Product code
FXY
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-17
Date received
2022-07-25
Regulation
878.4040
Classification name
Hood, Surgical
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karl Hintermann
Address
Gewerbestrasse 4 Feistritz Im Rosental AT 9181 9181

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FXY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverStryker Corporation2020-03-21
K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSStryker Corporation2014-06-26
K904969HOOD, OPERATING, SURGICALChicago Assoc. For Retarded Citizens1990-12-12
K904276DISPOSABLE BEARD COVERAnago, Inc.1990-11-21
K903533STERI-SHIELDBiomedical Devices, Inc.1990-10-19
K902677STERI-SHIELDBiomedical Devices, Inc.1990-08-17
K880431CARETEX SURGEON'S HOODSJames River Corp.1988-02-24
K770261HOOD, CLARION SURGEONSSherwood Medical Industries1977-03-01
K770257HOOD & BEARD COVER, CLARION SURGEON'SSherwood Medical Industries1977-02-25
K761070P.S.M. SURGICAL HOODThe Owenby Co.1976-12-30
K760855BARRIER SURGICAL HOODSurgikos, Inc.1976-11-03
K760865BARRIER FASHION BONNETSurgikos, Inc.1976-11-03