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FDA 510(k)

ARTHROTAP

K-Number: K201816 · 2020-10-16

ApplicantAccuro Technologies, Inc.
Decision Date2020-10-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARTHROTAP is a medical device manufactured by Accuro Technologies, Inc.. It received FDA 510(k) clearance on 2020-10-16 under approval number K201816. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROTAP?

ARTHROTAP is a medical device that received FDA 510(k) clearance on 2020-10-16. It is manufactured by Accuro Technologies, Inc.. The 510(k) number is K201816.

When was ARTHROTAP approved by the FDA?

ARTHROTAP received FDA 510(k) clearance on 2020-10-16, under approval number K201816.

What company makes ARTHROTAP?

ARTHROTAP is manufactured by Accuro Technologies, Inc..

What is the FDA product code for ARTHROTAP?

The FDA product code for ARTHROTAP is FMF.

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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.

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