FDA 510(k)

NHanceIT

K-Number: K260559 · 2026-08-14

Decision Date2026-08-14

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NHanceIT is the device name listed in this FDA 510(k) record. The listed applicant is IMDS Operation B.V.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K260559. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NHanceIT?

NHanceIT is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is IMDS Operation B.V.. The 510(k) number is K260559.

When did NHanceIT receive FDA 510(k) clearance?

NHanceIT received FDA 510(k) clearance on 2026-08-14, under 510(k) number K260559.

Who is the listed applicant for NHanceIT?

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

What is the FDA product code for NHanceIT?

The FDA product code for NHanceIT is DQY.

Related Devices (Code: DQY)

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.