K241272 is an FDA 510(k) clearance for the Stryker Steri-Shield 8 Surgical Hoods and Togas. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on October 16, 2024, 163 days after receiving the submission on May 6, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K241272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2024 |
| Decision Date | October 16, 2024 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |