K101560 is an FDA 510(k) clearance for the MEDLINE RETRACTABLE SAFETY SYRINGE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 25, 2011, 294 days after receiving the submission on June 4, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K101560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2010 |
| Decision Date | March 25, 2011 |
| Days to Decision | 294 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG — Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |