510(k) K180650
K180650 is an FDA 510(k) premarket notification submitted by Amsel Medical Corporation for the device "Amsel Endo Occluder". The FDA issued a decision of Substantially Equivalent on November 15, 2018. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Amsel Medical Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2018
- Date Received
- March 13, 2018
- 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