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Syntheon, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232295LAA Exclusion SystemAugust 30, 2023
K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideOctober 28, 2022
K080317ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.April 29, 2008