510(k) K230966
K230966 is an FDA 510(k) premarket notification submitted by A2 Medical Systems, LLC for the device "angiOCCLUDE Ligating Clips". The FDA issued a decision of Substantially Equivalent on September 19, 2023. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. A2 Medical Systems, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2023
- Date Received
- April 5, 2023
- 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