Submission Details
| 510(k) Number | K222744 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 2022 |
| Decision Date | October 11, 2022 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
Sol-M Luer Lock Syringe
Oct 2022
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K222744 is an FDA 510(k) clearance for the Sol-M Luer Lock Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Sol-Millennium Medical, Inc. (Suwanee, US). The FDA issued a Cleared decision on October 11, 2022, 29 days after receiving the submission on September 12, 2022. 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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