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FDA 510(k)

Milieve (YPS-301BD)

K-Number: K233751 · 2024-06-03

ApplicantSoterix Medical, Inc.
Decision Date2024-06-03
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Milieve (YPS-301BD) is the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2024-06-03 under 510(k) number K233751. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Milieve (YPS-301BD)?

Milieve (YPS-301BD) is a medical device that received FDA 510(k) clearance on 2024-06-03. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K233751.

When did Milieve (YPS-301BD) receive FDA 510(k) clearance?

Milieve (YPS-301BD) received FDA 510(k) clearance on 2024-06-03, under 510(k) number K233751.

Who is the listed applicant for Milieve (YPS-301BD)?

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

What is the FDA product code for Milieve (YPS-301BD)?

The FDA product code for Milieve (YPS-301BD) is PCC.

Other records listing Soterix Medical, Inc. as applicant

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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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