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Endophys Holdings, LLC

FDA Regulatory Profile

Endophys Holdings, LLC has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 17, 2016 · NAI
Latest 510(k)
Mar 7, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 17, 2016Dallas, TXDevicesNo Action Indicated (NAI)3011493920

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K190098Endophys Pressure Sensing SheathMar 7, 2019
K180620Endophys Pressure Sensing Sheath KitOct 12, 2018
K173399Endophys Pressure Sensing Sheath Kit- 8FNov 30, 2017
K160945Endophys Blood Pressure MonitorSep 26, 2016

FDA data resources