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FDA 510(k)

UROSCOPE, ARTES MEDICAL, USA

K-Number: K003988 · 2001-09-06

ApplicantArtes Medical USA, Inc.
Decision Date2001-09-06
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROSCOPE, ARTES MEDICAL, USA is the device name listed in this FDA 510(k) record. The listed applicant is Artes Medical USA, Inc.. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K003988. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROSCOPE, ARTES MEDICAL, USA?

UROSCOPE, ARTES MEDICAL, USA is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is Artes Medical USA, Inc.. The 510(k) number is K003988.

When did UROSCOPE, ARTES MEDICAL, USA receive FDA 510(k) clearance?

UROSCOPE, ARTES MEDICAL, USA received FDA 510(k) clearance on 2001-09-06, under 510(k) number K003988.

Who is the listed applicant for UROSCOPE, ARTES MEDICAL, USA?

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

What is the FDA product code for UROSCOPE, ARTES MEDICAL, USA?

The FDA product code for UROSCOPE, ARTES MEDICAL, USA is FAJ.

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Related Devices (Code: FAJ)

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Official Source

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