FDA 510(k)

GM501 Wash

K-Number: K190383 · 2019-09-05

Decision Date2019-09-05

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GM501 Wash is a medical device manufactured by Hamilton Thorne, Inc.. It received FDA 510(k) clearance on 2019-09-05 under approval number K190383. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GM501 Wash?

GM501 Wash is a medical device that received FDA 510(k) clearance on 2019-09-05. It is manufactured by Hamilton Thorne, Inc.. The 510(k) number is K190383.

When was GM501 Wash approved by the FDA?

GM501 Wash received FDA 510(k) clearance on 2019-09-05, under approval number K190383.

What company makes GM501 Wash?

GM501 Wash is manufactured by Hamilton Thorne, Inc..

What is the FDA product code for GM501 Wash?

The FDA product code for GM501 Wash is MQL.

Other Devices by Hamilton Thorne, Inc.

K191552GM501 Mineral Oil K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.