510(k) K201234
K201234 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD SoloShot Mini Syringe/ BD Auto Disable Syringe". The FDA issued a decision of Substantially Equivalent on Jul 15, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Becton, Dickinson And Company has 329 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 15, 2020
- Date Received
- May 7, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)