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FDA 510(k)

FERTI-LILY Conception Cup

K-Number: K222969 · 2023-06-23

ApplicantRosesta Medical BV
Decision Date2023-06-23
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FERTI-LILY Conception Cup is the device name listed in this FDA 510(k) record. The listed applicant is Rosesta Medical BV. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K222969. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERTI-LILY Conception Cup?

FERTI-LILY Conception Cup is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Rosesta Medical BV. The 510(k) number is K222969.

When did FERTI-LILY Conception Cup receive FDA 510(k) clearance?

FERTI-LILY Conception Cup received FDA 510(k) clearance on 2023-06-23, under 510(k) number K222969.

Who is the listed applicant for FERTI-LILY Conception Cup?

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

What is the FDA product code for FERTI-LILY Conception Cup?

The FDA product code for FERTI-LILY Conception Cup is HDR.

Related Devices (Code: HDR)

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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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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