K203548 is an FDA 510(k) clearance for the EndoArmor™ + Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on February 21, 2022, 444 days after receiving the submission on December 4, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2020 |
| Decision Date | February 21, 2022 |
| Days to Decision | 444 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 |