K213054 is an FDA 510(k) clearance for the Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on December 9, 2022, 443 days after receiving the submission on September 22, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K213054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2021 |
| Decision Date | December 09, 2022 |
| Days to Decision | 443 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 |