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FDA 510(k)

VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN

K-Number: K113545 · 2012-02-27

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2012-02-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2012-02-27 under 510(k) number K113545. 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 VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN?

VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN is a medical device that received FDA 510(k) clearance on 2012-02-27. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K113545.

When did VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN receive FDA 510(k) clearance?

VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN received FDA 510(k) clearance on 2012-02-27, under 510(k) number K113545.

Who is the listed applicant for VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN?

The FDA product code for VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN 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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