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FDA 510(k)

MEDRANGE ELECTROSURGICAL GENERATOR

K-Number: K102114 · 2010-11-22

ApplicantMedrange Corporation
Decision Date2010-11-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDRANGE ELECTROSURGICAL GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medrange Corporation. It received FDA 510(k) clearance on 2010-11-22 under 510(k) number K102114. 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 MEDRANGE ELECTROSURGICAL GENERATOR?

MEDRANGE ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 2010-11-22. The listed applicant is Medrange Corporation. The 510(k) number is K102114.

When did MEDRANGE ELECTROSURGICAL GENERATOR receive FDA 510(k) clearance?

MEDRANGE ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 2010-11-22, under 510(k) number K102114.

Who is the listed applicant for MEDRANGE ELECTROSURGICAL GENERATOR?

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

What is the FDA product code for MEDRANGE ELECTROSURGICAL GENERATOR?

The FDA product code for MEDRANGE ELECTROSURGICAL GENERATOR is GEI.

Related Clinical Trials

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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Other records listing Medrange 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.

K122092MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM

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.

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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.

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