K141693 is an FDA 510(k) clearance for the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on December 19, 2014, 178 days after receiving the submission on June 24, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K141693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2014 |
| Decision Date | December 19, 2014 |
| Days to Decision | 178 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 |