FDA 510(k)

AUTOCON II 400 ELECTROSURGICAL GENERATOR

K-Number: K021467 · 2002-11-04

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date2002-11-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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 2002-11-04 under 510(k) number K021467. 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 AUTOCON II 400 ELECTROSURGICAL GENERATOR?

AUTOCON II 400 ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 2002-11-04. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K021467.

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

AUTOCON II 400 ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 2002-11-04, under 510(k) number K021467.

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

The FDA product code for 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.