FDA 510(k)

trophon2

K-Number: K250434 · 2025-08-05

Decision Date2025-08-05

Product CodeOUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

trophon2 is the device name listed in this FDA 510(k) record. The listed applicant is Nanosonics. It received FDA 510(k) clearance on 2025-08-05 under 510(k) number K250434. The device is classified under product code OUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the trophon2?

trophon2 is a medical device that received FDA 510(k) clearance on 2025-08-05. The listed applicant is Nanosonics. The 510(k) number is K250434.

When did trophon2 receive FDA 510(k) clearance?

trophon2 received FDA 510(k) clearance on 2025-08-05, under 510(k) number K250434.

Who is the listed applicant for trophon2?

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

What is the FDA product code for trophon2?

The FDA product code for trophon2 is OUJ.

Other records listing Nanosonics 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.

K253267CORIS System K241536trophon Wireless Ultrasound Probe Holder K173865trophon2

Related Devices (Code: OUJ)

K241536trophon Wireless Ultrasound Probe HolderNanosonics Limited K173865trophon2Nanosonics Limited

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.