Submission Details
| 510(k) Number | K241821 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 2024 |
| Decision Date | September 20, 2024 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle
Sep 2024
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K241821 is an FDA 510(k) clearance for the Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Sol-Millennium Medical, Inc. (Chicago, US). The FDA issued a Cleared decision on September 20, 2024, 88 days after receiving the submission on June 24, 2024. 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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