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FDA 510(k)

INTEGRATED VISUALIZATION SYSTEM

K-Number: K970598 · 1997-03-12

ApplicantUrohealth, Inc.
Decision Date1997-03-12
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTEGRATED VISUALIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Urohealth, Inc.. It received FDA 510(k) clearance on 1997-03-12 under 510(k) number K970598. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRATED VISUALIZATION SYSTEM?

INTEGRATED VISUALIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-12. The listed applicant is Urohealth, Inc.. The 510(k) number is K970598.

When did INTEGRATED VISUALIZATION SYSTEM receive FDA 510(k) clearance?

INTEGRATED VISUALIZATION SYSTEM received FDA 510(k) clearance on 1997-03-12, under 510(k) number K970598.

Who is the listed applicant for INTEGRATED VISUALIZATION SYSTEM?

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

What is the FDA product code for INTEGRATED VISUALIZATION SYSTEM?

The FDA product code for INTEGRATED VISUALIZATION SYSTEM is FCW.

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Related Devices (Code: FCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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