Atlas FDA

FXY

13 FDA 510(k) clearances · Product code

37 daysmedian time to decision
111 days90th percentile
13clearances measured

FDA profile

Official device name
Hood, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (K222214)Thi Total Healthcare Innovation GmbH2023-10-17
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover (K200493)Stryker Corporation2020-03-21
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (K140588)Stryker Corporation2014-06-26
HOOD, OPERATING, SURGICAL (K904969)Chicago Assoc. For Retarded Citizens1990-12-12
DISPOSABLE BEARD COVER (K904276)Anago, Inc.1990-11-21
STERI-SHIELD (K903533)Biomedical Devices, Inc.1990-10-19
STERI-SHIELD (K902677)Biomedical Devices, Inc.1990-08-17
CARETEX SURGEON'S HOODS (K880431)James River Corp.1988-02-24
HOOD, CLARION SURGEONS (K770261)Sherwood Medical Industries1977-03-01
HOOD & BEARD COVER, CLARION SURGEON'S (K770257)Sherwood Medical Industries1977-02-25
P.S.M. SURGICAL HOOD (K761070)The Owenby Co.1976-12-30
BARRIER FASHION BONNET (K760865)Surgikos, Inc.1976-11-03
BARRIER SURGICAL HOOD (K760855)Surgikos, Inc.1976-11-03

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Every clearance here is in the API, with alerts when new ones post.