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Endophys Holdings, LLC

FDA Regulatory Profile

Endophys Holdings, LLC appears in FDA public data with 0 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 7, 2019.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K190098Endophys Pressure Sensing SheathMarch 7, 2019
K180620Endophys Pressure Sensing Sheath KitOctober 12, 2018
K173399Endophys Pressure Sensing Sheath Kit- 8FNovember 30, 2017
K160945Endophys Blood Pressure MonitorSeptember 26, 2016

FDA data resources