FDA 510(k)

AUTOCON III 400

K-Number: K171717 · 2017-08-02

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date2017-08-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AUTOCON III 400 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 2017-08-02 under 510(k) number K171717. 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 III 400?

AUTOCON III 400 is a medical device that received FDA 510(k) clearance on 2017-08-02. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K171717.

When did AUTOCON III 400 receive FDA 510(k) clearance?

AUTOCON III 400 received FDA 510(k) clearance on 2017-08-02, under 510(k) number K171717.

Who is the listed applicant for AUTOCON III 400?

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 III 400?

The FDA product code for AUTOCON III 400 is GEI.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.