K200335 is an FDA 510(k) clearance for the Sterisheet Sterilization Wrap. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on November 12, 2020, 275 days after receiving the submission on February 11, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K200335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2020 |
| Decision Date | November 12, 2020 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |