Hood, Surgical
A surgical hood is a head and neck covering worn by members of the surgical team to prevent contamination of the sterile operative field from hair and skin particles, particularly in environments requiring enhanced infection control. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FXY, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FXY
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Oct 17, 2023 | Substantially Equivalent | Thi Total Healthcare Innovation GmbH |
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover | Mar 21, 2020 | Substantially Equivalent | Stryker Corporation |
| K140588 | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS | Jun 26, 2014 | Substantially Equivalent | Stryker Corporation |
| K904969 | HOOD, OPERATING, SURGICAL | Dec 12, 1990 | Substantially Equivalent | Chicago Assoc. For Retarded Citizens |
| K904276 | DISPOSABLE BEARD COVER | Nov 21, 1990 | Substantially Equivalent | Anago, Inc. |
| K903533 | STERI-SHIELD | Oct 19, 1990 | Substantially Equivalent | Biomedical Devices, Inc. |
| K902677 | STERI-SHIELD | Aug 17, 1990 | Substantially Equivalent | Biomedical Devices, Inc. |
| K880431 | CARETEX SURGEON'S HOODS | Feb 24, 1988 | Substantially Equivalent | James River Corp. |
| K770261 | HOOD, CLARION SURGEONS | Mar 01, 1977 | Substantially Equivalent | Sherwood Medical Industries |
| K770257 | HOOD & BEARD COVER, CLARION SURGEON'S | Feb 25, 1977 | Substantially Equivalent | Sherwood Medical Industries |
| K761070 | P.S.M. SURGICAL HOOD | Dec 30, 1976 | Substantially Equivalent | The Owenby Co. |
| K760865 | BARRIER FASHION BONNET | Nov 03, 1976 | Substantially Equivalent | Surgikos, Inc. |
| K760855 | BARRIER SURGICAL HOOD | Nov 03, 1976 | Substantially Equivalent | Surgikos, Inc. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.