K210200 is an FDA 510(k) clearance for the 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock. 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 May 14, 2021, 109 days after receiving the submission on January 25, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K210200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2021 |
| Decision Date | May 14, 2021 |
| Days to Decision | 109 days |
| Submission Type | Special |
| 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 |