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FDA 510(k)

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

K-Number: K241132 · 2024-12-18

ApplicantArtsmedia Denmark Aps
Decision Date2024-12-18
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) is a medical device manufactured by Artsmedia Denmark Aps. It received FDA 510(k) clearance on 2024-12-18 under approval number K241132. 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 ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)?

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Artsmedia Denmark Aps. The 510(k) number is K241132.

When was ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) approved by the FDA?

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) received FDA 510(k) clearance on 2024-12-18, under approval number K241132.

What company makes ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)?

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) is manufactured by Artsmedia Denmark Aps.

What is the FDA product code for ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)?

The FDA product code for ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) is MQL.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Artsmedia Denmark Aps

K220715ARTSMedia In Vitro Culture Medium (AM-IVC Medium) K241095ARTSMedia Semen Wash Medium

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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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