FDA 510(k)

Neurophet AQUA

K-Number: K261273 · 2026-05-15

Decision Date2026-05-15

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Neurophet AQUA is the device name listed in this FDA 510(k) record. The listed applicant is Neurophet., Inc.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K261273. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurophet AQUA?

Neurophet AQUA is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Neurophet., Inc.. The 510(k) number is K261273.

When did Neurophet AQUA receive FDA 510(k) clearance?

Neurophet AQUA received FDA 510(k) clearance on 2026-05-15, under 510(k) number K261273.

Who is the listed applicant for Neurophet AQUA?

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

What is the FDA product code for Neurophet AQUA?

The FDA product code for Neurophet AQUA is QIH.

Other records listing Neurophet., Inc. 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.

K252563Neurophet SCALE PET K252496Neurophet AQUA AD Plus K242215Neurophet AQUA (V3.1)K220437Neurophet AQUA K221405Neurophet SCALE PET

Related Devices (Code: QIH)

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbH K253902RealGUIDE3DIEMME SRL K253835AffinityHermes Medical Solutions AB K260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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.