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FDA 510(k)

INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM

K-Number: K042069 · 2004-11-01

ApplicantAcmi Corporation
Decision Date2004-11-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2004-11-01 under 510(k) number K042069. 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 INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM?

INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-01. The listed applicant is Acmi Corporation. The 510(k) number is K042069.

When did INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM receive FDA 510(k) clearance?

INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM received FDA 510(k) clearance on 2004-11-01, under 510(k) number K042069.

Who is the listed applicant for INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM?

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

What is the FDA product code for INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM?

The FDA product code for INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM is GCJ.

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Other records listing Acmi Corporation as applicant

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Related Devices (Code: 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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