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FDA 510(k)

Werewolf RF20000 Controller, FLOW 50 Wand

K-Number: K162074 · 2016-08-22

Decision Date2016-08-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Werewolf RF20000 Controller, FLOW 50 Wand is a medical device manufactured by ArthroCare Corporation. It received FDA 510(k) clearance on 2016-08-22 under approval number K162074. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Werewolf RF20000 Controller, FLOW 50 Wand?

Werewolf RF20000 Controller, FLOW 50 Wand is a medical device that received FDA 510(k) clearance on 2016-08-22. It is manufactured by ArthroCare Corporation. The 510(k) number is K162074.

When was Werewolf RF20000 Controller, FLOW 50 Wand approved by the FDA?

Werewolf RF20000 Controller, FLOW 50 Wand received FDA 510(k) clearance on 2016-08-22, under approval number K162074.

What company makes Werewolf RF20000 Controller, FLOW 50 Wand?

Werewolf RF20000 Controller, FLOW 50 Wand is manufactured by ArthroCare Corporation.

What is the FDA product code for Werewolf RF20000 Controller, FLOW 50 Wand?

The FDA product code for Werewolf RF20000 Controller, FLOW 50 Wand is GEI.

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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.