Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2016-08-22 under 510(k) 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. The listed applicant is ArthroCare Corporation. The 510(k) number is K162074.

When did Werewolf RF20000 Controller, FLOW 50 Wand receive FDA 510(k) clearance?

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

Who is the listed applicant for Werewolf RF20000 Controller, FLOW 50 Wand?

The FDA 510(k) record lists ArthroCare Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing ArthroCare Corporation 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.

View all 18 devices →

Related Devices (Code: GEI)

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.

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.