510(k) K201816
K201816 is an FDA 510(k) premarket notification submitted by Accuro Technologies, Inc. for the device "ARTHROTAP". The FDA issued a decision of Substantially Equivalent on Oct 16, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2020
- Date Received
- Jul 1, 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)