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Neosurgical, Ltd.

FDA Regulatory Profile

Neosurgical, Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 7, 2017 · NAI
Latest 510(k)
Nov 8, 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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 7, 2017Galway, IrelandDevicesNo Action Indicated (NAI)3010054951

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
K173917neoClose PDSNov 8, 2018
K142903neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack USNov 12, 2014
K131688NEOCLOSE HASSON, NEOCLOSE UNIVERSALJul 18, 2013
K123280NEOCLOSE HASSON, NEOCLOSE UNIVERSALApr 18, 2013

FDA data resources