510(k) K213813
K213813 is an FDA 510(k) premarket notification submitted by Neuramedica, Inc. for the device "DuraFuse Clip and Applier System". The FDA issued a decision of Substantially Equivalent on July 22, 2022. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2022
- Date Received
- December 7, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type