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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 the device name listed in this FDA 510(k) record. The listed applicant is Nanofiber Solutions, LLC. It received FDA 510(k) clearance on 2025-02-27 under 510(k) 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. The listed applicant is Nanofiber Solutions, LLC. The 510(k) number is K250021.

When did Rotium receive FDA 510(k) clearance?

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

Who is the listed applicant for Rotium?

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

What is the FDA product code for Rotium?

The FDA product code for Rotium is OWW.

Other records listing Nanofiber Solutions, LLC 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.

K241912BIOCHARGEK231641Rotium Bioresorbable WickK201414Rotium Bioresorbable WickK183236Rotium Bioresorbable WickK173544Phoenix Wound Matrix

Related Devices (Code: OWW)

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.

K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair BiosciencesK242187BioBrace®Conmed CorporationK241906BioBrace® Reinforced ImplantConmed CorporationK240817VersaWrapAlafair Biosciences, Inc.K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences

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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