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FDA 510(k)

SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY

K-Number: K050161 · 2005-02-03

ApplicantConmed Electrosurgery
Decision Date2005-02-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Electrosurgery. It received FDA 510(k) clearance on 2005-02-03 under 510(k) number K050161. 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 SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY?

SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY is a medical device that received FDA 510(k) clearance on 2005-02-03. The listed applicant is Conmed Electrosurgery. The 510(k) number is K050161.

When did SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY receive FDA 510(k) clearance?

SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY received FDA 510(k) clearance on 2005-02-03, under 510(k) number K050161.

Who is the listed applicant for SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY?

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

What is the FDA product code for SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY?

The FDA product code for SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY is GEI.

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Related Devices (Code: GEI)

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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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