K101708 is an FDA 510(k) clearance for the PATIENT SAFE LUER CAP. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Retractable Technologies, Inc. (Little Elm, US). The FDA issued a Cleared decision on February 24, 2011, 252 days after receiving the submission on June 17, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K101708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2010 |
| Decision Date | February 24, 2011 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |