K180672 is an FDA 510(k) clearance for the Sterilization Pouch/Roll Made with Tyvek. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Sigma Medical Supplies Corporation (New Taipei City, TW). The FDA issued a Cleared decision on June 6, 2018, 84 days after receiving the submission on March 14, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K180672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2018 |
| Decision Date | June 06, 2018 |
| Days to Decision | 84 days |
| Submission Type | Abbreviated |
| 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 |