Guangzhou T.K Medical Instrument Co., Ltd.

FDA Regulatory Profile

Guangzhou T.K Medical Instrument Co., Ltd. has 0 FDA recalls, 3 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 23, 2024 · NAI
Latest 510(k)
Jul 9, 2020

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 23, 2024Guangzhou, ChinaDevicesNo Action Indicated (NAI)3008191256
May 15, 2021Guangzhou, ChinaDevicesNo Action Indicated (NAI)3008191256
Jan 15, 2015Guangzhou, ChinaDevicesVoluntary Action Indicated (VAI)3008191256

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
K193272GTK TrocarsJul 9, 2020
K193339GTK Veress NeedlesJan 30, 2020