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Acrostak (Schweiz) AG

FDA Regulatory Profile

Acrostak (Schweiz) AG has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 1 compliance action on record.

Latest inspection
Jun 15, 2023 · OAI
Latest 510(k)
Sep 15, 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) clearances1Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 15, 2023Winterthur, SwitzerlandDevicesOfficial Action Indicated (OAI)3005086865

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
K171176M-CATH MicrocatheterSep 15, 2017

FDA data resources