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FDA 510(k)

VEIN-GOGH INSTRUMENT

K-Number: K112334 · 2012-05-08

ApplicantRefine USA, LLC
Decision Date2012-05-08
Product CodeONQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VEIN-GOGH INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Refine USA, LLC. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K112334. The device is classified under product code ONQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VEIN-GOGH INSTRUMENT?

VEIN-GOGH INSTRUMENT is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Refine USA, LLC. The 510(k) number is K112334.

When did VEIN-GOGH INSTRUMENT receive FDA 510(k) clearance?

VEIN-GOGH INSTRUMENT received FDA 510(k) clearance on 2012-05-08, under 510(k) number K112334.

Who is the listed applicant for VEIN-GOGH INSTRUMENT?

The FDA 510(k) record lists Refine USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VEIN-GOGH INSTRUMENT?

The FDA product code for VEIN-GOGH INSTRUMENT is ONQ.

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Other records listing Refine USA, LLC 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.

K192138Rejuvapen NXT

Related Devices (Code: ONQ)

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.

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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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