K222925 is an FDA 510(k) clearance for the Hypodermic Syringes & Needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Lifelong Meditech Private Limited (Gurgaon, IN). The FDA issued a Cleared decision on July 18, 2023, 295 days after receiving the submission on September 26, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K222925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | July 18, 2023 |
| Days to Decision | 295 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 |