K022162 is an FDA 510(k) clearance for the STRYKER T4 URETHANE HOOD. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 1, 2002, 29 days after receiving the submission on July 3, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K022162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2002 |
| Decision Date | August 01, 2002 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |