K192194 is an FDA 510(k) clearance for the TotalShield II Surgical Helmet System. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Zimmer Surgical, Inc. (Dover, US). The FDA issued a Cleared decision on October 15, 2019, 63 days after receiving the submission on August 13, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K192194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2019 |
| Decision Date | October 15, 2019 |
| Days to Decision | 63 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |