K201234 is an FDA 510(k) clearance for the BD SoloShot Mini Syringe/ BD Auto Disable Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on July 15, 2020, 69 days after receiving the submission on May 7, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K201234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2020 |
| Decision Date | July 15, 2020 |
| Days to Decision | 69 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 |