Syntheon
FDA Regulatory Profile
Syntheon appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 30, 2023.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232295 | LAA Exclusion System | August 30, 2023 |
| K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | October 28, 2022 |
| K080317 | ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11. | April 29, 2008 |