Submission Details
| 510(k) Number | K213054 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Dec 2022
Decision
443d
Days
Class 2
Risk
About This 510(k) Submission
K213054 is an FDA 510(k) clearance for the Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Medline Industries, Inc. (Nortfield, 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 review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
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