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FDA 510(k)

GM501 SpermAir and GM501 SpermActive

K-Number: K192644 · 2020-04-23

ApplicantHamilton Thorne Incorporated
Decision Date2020-04-23
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GM501 SpermAir and GM501 SpermActive is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne Incorporated. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K192644. 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 SpermAir and GM501 SpermActive?

GM501 SpermAir and GM501 SpermActive is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Hamilton Thorne Incorporated. The 510(k) number is K192644.

When did GM501 SpermAir and GM501 SpermActive receive FDA 510(k) clearance?

GM501 SpermAir and GM501 SpermActive received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192644.

Who is the listed applicant for GM501 SpermAir and GM501 SpermActive?

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

What is the FDA product code for GM501 SpermAir and GM501 SpermActive?

The FDA product code for GM501 SpermAir and GM501 SpermActive is MQL.

Other records listing Hamilton Thorne Incorporated 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 GentamicinK191552GM501 Mineral OilK190383GM501 Wash

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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