K201284 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Set Medikal Sanayi VE Ticaret Anonim Sirketi (Istanbul, TR). The FDA issued a Cleared decision on December 14, 2020, 215 days after receiving the submission on May 13, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K201284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2020 |
| Decision Date | December 14, 2020 |
| Days to Decision | 215 days |
| Submission Type | Abbreviated |
| 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 |