P.S.M. Surgical Hood
FDA 510(k) K761070 · The Owenby Co.
510(k) numberK761070
Submission
- Device name
- P.S.M. Surgical Hood
- Applicant
- The Owenby Co.
Mchenry, IL, US - Received
- November 16, 1976
- Decision date
- December 30, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FXY – Hood, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)FXY · Traditional | Thi Total Healthcare Innovation GmbH | 10/17/2023SE |
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical…FXY · Traditional | Stryker Corporation | 03/21/2020SE |
| K140588 | Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensFXY · Special | Stryker Corporation | 06/26/2014SE |
| K904969 | Hood, Operating, SurgicalFXY · Traditional | Chicago Assoc. For Retarded Citizens | 12/12/1990SE |
| K904276 | Disposable Beard CoverFXY · Traditional | Anago, Inc. | 11/21/1990SE |
| K903533 | Steri-ShieldFXY · Traditional | Biomedical Devices, Inc. | 10/19/1990SE |
| K902677 | Steri-ShieldFXY · Traditional | Biomedical Devices, Inc. | 08/17/1990SE |
| K880431 | Caretex Surgeon's HoodsFXY · Traditional | James River Corp. | 02/24/1988SE |
| K770261 | Hood, Clarion SurgeonsFXY · Traditional | Sherwood Medical Industries | 03/01/1977SE |
| K770257 | Hood & Beard Cover, Clarion Surgeon'sFXY · Traditional | Sherwood Medical Industries | 02/25/1977SE |
More from Sherwood Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K801628 | Restraint, ProtectiveIQK · Traditional | 08/07/1980SE |
| K801627 | Cover, LimbIPM · Traditional | 07/28/1980SE |
| K801626 | Arm SlingILI · Traditional | 07/28/1980SE |
| K801532 | Stockinette, Sterile Two Ply W/Pull TabsFQM · Traditional | 07/28/1980SE |
| K801531 | Arm SlingILI · Traditional | 07/21/1980SE |
| K790210 | Stockinette, Tubular UnbleachedFQM · Traditional | 02/27/1979SE |
| K780764 | Non-Sterile Folded GauzeNAB · Traditional | 06/06/1978SE |
| K780418 | Burn Dressing PadFPY · Traditional | 04/10/1978SE |
| K770889 | Burn Dressing KitEFQ · Traditional | 07/11/1977SE |
| K761071 | P.S.M. Justa KapFYF · Traditional | 12/30/1976SE |
Questions and answers
When was P.S.M. Surgical Hood cleared by the FDA?
P.S.M. Surgical Hood (K761070) received a 510(k) decision of Substantially Equivalent on December 30, 1976, 44 days after the submission was received.
What is the product code of K761070?
The FDA product code is FXY – Hood, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.