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Prescient Surgical

FDA Regulatory Profile

Prescient Surgical has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 19, 2019 · VAI
Latest 510(k)
Oct 25, 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) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 19, 2019San Carlos, CADevicesVoluntary Action Indicated (VAI)3014131608

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
K172132CleanCision Wound Retraction and Protection SystemOct 25, 2017
DEN150038CleanCisionTM Wound Retraction and Protection SystemDec 16, 2016

FDA data resources