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Sigma Medical Supplies Corp.

FDA Regulatory Profile

Sigma Medical Supplies Corp. has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 13, 2017 · VAI
Latest 510(k)
Apr 23, 2021

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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
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 13, 2017Taoyuan, TaiwanDevicesVoluntary Action Indicated (VAI)3004970050

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
K202462SIGMA Sterilization Pouch and RollApr 23, 2021
K180672Sterilization Pouch/Roll Made with TyvekJun 6, 2018
K180661SIGMA Sterilization Pouch and RollJun 5, 2018
K133838STERILIZATION POUCH/ROLL MADE WITH TYVEKMar 11, 2015
K102158SIGMA STERILIZATION POUCH & ROLLAug 2, 2011

FDA data resources