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Q Urological Corporation

FDA Regulatory Profile

Q Urological Corporation has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 16, 2020 · NAI
Latest 510(k)
Oct 4, 2017

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 16, 2020Medfield, MADevicesNo Action Indicated (NAI)3014292835

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
K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentOct 4, 2017
K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentDec 22, 2016
K082805PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXXJan 20, 2010

FDA data resources