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FDA 510(k)

Rotium

K-Number: K250021 · 2025-02-27

ApplicantNanofiber Solutions, LLC
Decision Date2025-02-27
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rotium is a medical device manufactured by Nanofiber Solutions, LLC. It received FDA 510(k) clearance on 2025-02-27 under approval number K250021. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rotium?

Rotium is a medical device that received FDA 510(k) clearance on 2025-02-27. It is manufactured by Nanofiber Solutions, LLC. The 510(k) number is K250021.

When was Rotium approved by the FDA?

Rotium received FDA 510(k) clearance on 2025-02-27, under approval number K250021.

What company makes Rotium?

Rotium is manufactured by Nanofiber Solutions, LLC.

What is the FDA product code for Rotium?

The FDA product code for Rotium is OWW.

Other Devices by Nanofiber Solutions, LLC

K183236Rotium Bioresorbable Wick K201414Rotium Bioresorbable Wick K231641Rotium Bioresorbable Wick K241912BIOCHARGE

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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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