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FDA 510(k)

INNERVUE DIAGNOSTIC SCOPE SYSTEM

K-Number: K040604 · 2004-06-04

ApplicantArthrotek, Inc.
Decision Date2004-06-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNERVUE DIAGNOSTIC SCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek, Inc.. It received FDA 510(k) clearance on 2004-06-04 under 510(k) number K040604. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNERVUE DIAGNOSTIC SCOPE SYSTEM?

INNERVUE DIAGNOSTIC SCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-04. The listed applicant is Arthrotek, Inc.. The 510(k) number is K040604.

When did INNERVUE DIAGNOSTIC SCOPE SYSTEM receive FDA 510(k) clearance?

INNERVUE DIAGNOSTIC SCOPE SYSTEM received FDA 510(k) clearance on 2004-06-04, under 510(k) number K040604.

Who is the listed applicant for INNERVUE DIAGNOSTIC SCOPE SYSTEM?

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

What is the FDA product code for INNERVUE DIAGNOSTIC SCOPE SYSTEM?

The FDA product code for INNERVUE DIAGNOSTIC SCOPE SYSTEM is GCJ.

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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.

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