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FDA 510(k)

GM501 Wash

K-Number: K190383 · 2019-09-05

ApplicantHamilton Thorne, Inc.
Decision Date2019-09-05
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GM501 Wash is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne, Inc.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) 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. The listed applicant is Hamilton Thorne, Inc.. The 510(k) number is K190383.

When did GM501 Wash receive FDA 510(k) clearance?

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

Who is the listed applicant for GM501 Wash?

The FDA 510(k) record lists Hamilton Thorne, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GM501 Wash?

The FDA product code for GM501 Wash is MQL.

Other records listing Hamilton Thorne, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202241LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)K192503GM501 Wash with Phenol Red and GentamicinK192644GM501 SpermAir and GM501 SpermActiveK191552GM501 Mineral Oil

Related Devices (Code: MQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

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.

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