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FDA 510(k)

FLOW 90 Wand

K-Number: K183346 · 2019-01-24

ApplicantArthroCare Corporation
Decision Date2019-01-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLOW 90 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 2019-01-24 under 510(k) number K183346. 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 FLOW 90 Wand?

FLOW 90 Wand is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is ArthroCare Corporation. The 510(k) number is K183346.

When did FLOW 90 Wand receive FDA 510(k) clearance?

FLOW 90 Wand received FDA 510(k) clearance on 2019-01-24, under 510(k) number K183346.

Who is the listed applicant for FLOW 90 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 FLOW 90 Wand?

The FDA product code for FLOW 90 Wand is GEI.

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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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