Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens
FDA 510(k) K140588 · Stryker Corporation
510(k) numberK140588
Submission
- Device name
- Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens
- Applicant
- Stryker Corporation
Kalamazoo, MI, US - Received
- March 7, 2014
- Decision date
- June 26, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K761070 | P.S.M. Surgical HoodFXY · Traditional | The Owenby Co. | 12/30/1976SE |
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Questions and answers
When was Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens cleared by the FDA?
Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens (K140588) received a 510(k) decision of Substantially Equivalent on June 26, 2014, 111 days after the submission was received.
What is the product code of K140588?
The FDA product code is FXY – Hood, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.