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Emcision , Ltd.

FDA Regulatory Profile

Emcision , Ltd. has 0 FDA recalls, 1 inspection, 10 510(k) clearances and 1 compliance action on record.

Latest inspection
Aug 14, 2014 · VAI
Latest 510(k)
Mar 20, 2018

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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) clearances10Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 14, 2014London, United KingdomDevicesVoluntary Action Indicated (VAI)3005442923

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
K180165Habib EndoHPBMar 20, 2018
K161305Habib EUS RFAJul 7, 2016
K150029Habib EUS RFAJun 24, 2015
K083292HABIB ENDOHPBJun 10, 2009
K080717HABIB HEXABLATE 10Mar 27, 2008
K073687HABIB LAPAROSCOPIC HEXABLATEJan 9, 2008
K072383HABIB ENDOBLATENov 29, 2007
K072126HABIB VESEALOct 2, 2007
K071103HABIB HEXABLATEJun 27, 2007
K051420HABIB 4XAug 15, 2005

FDA data resources