K170437 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 1, 2017, 261 days after receiving the submission on February 13, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K170437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2017 |
| Decision Date | November 01, 2017 |
| Days to Decision | 261 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 |