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FDA 510(k)

V-ONESTEP

K-Number: K193285 · 2020-11-20

ApplicantVitromed GmbH
Decision Date2020-11-20
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

V-ONESTEP is the device name listed in this FDA 510(k) record. The listed applicant is Vitromed GmbH. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K193285. 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 V-ONESTEP?

V-ONESTEP is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Vitromed GmbH. The 510(k) number is K193285.

When did V-ONESTEP receive FDA 510(k) clearance?

V-ONESTEP received FDA 510(k) clearance on 2020-11-20, under 510(k) number K193285.

Who is the listed applicant for V-ONESTEP?

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

What is the FDA product code for V-ONESTEP?

The FDA product code for V-ONESTEP is MQL.

Other records listing Vitromed GmbH 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.

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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

View on FDA Database →

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

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