K121664 is an FDA 510(k) clearance for the T4/T5 HYTREL TOGAS. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on March 10, 2014, 643 days after receiving the submission on June 5, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K121664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2012 |
| Decision Date | March 10, 2014 |
| Days to Decision | 643 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |