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FDA 510(k)

MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM

K-Number: K122092 · 2012-10-23

ApplicantMedrange Corporation
Decision Date2012-10-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medrange Corporation. It received FDA 510(k) clearance on 2012-10-23 under 510(k) number K122092. 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 EXPANSION SYSTEM?

MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-23. The listed applicant is Medrange Corporation. The 510(k) number is K122092.

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

MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM received FDA 510(k) clearance on 2012-10-23, under 510(k) number K122092.

Who is the listed applicant for MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM?

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 EXPANSION SYSTEM?

The FDA product code for MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM is GEI.

Related Clinical Trials

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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.

K102114MEDRANGE ELECTROSURGICAL GENERATOR

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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