K112774 is an FDA 510(k) clearance for the BD RECYKLEEN SHARPS COLLECTORS. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on March 28, 2012, 187 days after receiving the submission on September 23, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K112774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2011 |
| Decision Date | March 28, 2012 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MMK — Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |