K012931 is an FDA 510(k) clearance for the GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on August 20, 2002, 354 days after receiving the submission on August 31, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K012931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2001 |
| Decision Date | August 20, 2002 |
| Days to Decision | 354 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 |