FDA 510(k)

MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR

K-Number: K062464 · 2007-02-16

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date2007-02-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2007-02-16 under 510(k) number K062464. 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 MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR?

MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 2007-02-16. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K062464.

When did MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR receive FDA 510(k) clearance?

MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 2007-02-16, under 510(k) number K062464.

Who is the listed applicant for MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR?

The FDA product code for MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR is 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.