Focal Therapeutics

FDA Regulatory Profile

Focal Therapeutics has 0 FDA recalls, 3 inspections, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 26, 2018 · NAI
Latest 510(k)
Sep 26, 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) clearances5Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 26, 2018Sunnyvale, CADevicesNo Action Indicated (NAI)3009718212
Sep 13, 2016Aliso Viejo, CADevicesNo Action Indicated (NAI)3011179400
Jun 19, 2013Sunnyvale, CADevicesNo Action Indicated (NAI)3009718212

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
K192371BioZorb SP MarkerSep 26, 2019
K171467BioZorb Marker GOLD / LP Marker GOLDNov 9, 2017
K152070BioZorb LP MarkerAug 26, 2015
K143484BioZorb MarkerJun 29, 2015
K113202TISSUE MARKERFeb 28, 2012