K220713 is an FDA 510(k) clearance for the Sol-Guard Auto-disable Syringe. This device is classified as 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 May 4, 2023, 419 days after receiving the submission on March 11, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K220713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2022 |
| Decision Date | May 04, 2023 |
| Days to Decision | 419 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 |