510(k) K230966

angiOCCLUDE Ligating Clips by A2 Medical Systems, LLC — Product Code FZP

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