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FDA 510(k)

Rotium Bioresorbable Wick

K-Number: K183236 · 2019-03-11

ApplicantNanofiber Solutions, LLC
Decision Date2019-03-11
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Rotium Bioresorbable Wick is a medical device manufactured by Nanofiber Solutions, LLC. It received FDA 510(k) clearance on 2019-03-11 under approval number K183236. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rotium Bioresorbable Wick?

Rotium Bioresorbable Wick is a medical device that received FDA 510(k) clearance on 2019-03-11. It is manufactured by Nanofiber Solutions, LLC. The 510(k) number is K183236.

When was Rotium Bioresorbable Wick approved by the FDA?

Rotium Bioresorbable Wick received FDA 510(k) clearance on 2019-03-11, under approval number K183236.

What company makes Rotium Bioresorbable Wick?

Rotium Bioresorbable Wick is manufactured by Nanofiber Solutions, LLC.

What is the FDA product code for Rotium Bioresorbable Wick?

The FDA product code for Rotium Bioresorbable Wick is MAI.

Other Devices by Nanofiber Solutions, LLC

K201414Rotium Bioresorbable Wick K231641Rotium Bioresorbable Wick K241912BIOCHARGE K250021Rotium

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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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