Submission Details
| 510(k) Number | K242099 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 18, 2024 |
| Decision Date | October 22, 2024 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Sol-M? Slip Tip Syringe without Needle, Sol-M? Eccentric Tip Syringe without Needle
Oct 2024
Decision
96d
Days
Class 2
Risk
About This 510(k) Submission
K242099 is an FDA 510(k) clearance for the Sol-M? Slip Tip Syringe without Needle, Sol-M? Eccentric Tip Syringe without 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 October 22, 2024, 96 days after receiving the submission on July 18, 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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