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FDA 510(k)

USA SERIES LAPAROSCOPES

K-Number: K013165 · 2002-01-18

ApplicantCircon Acmi
Decision Date2002-01-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

USA SERIES LAPAROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Circon Acmi. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K013165. 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 USA SERIES LAPAROSCOPES?

USA SERIES LAPAROSCOPES is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Circon Acmi. The 510(k) number is K013165.

When did USA SERIES LAPAROSCOPES receive FDA 510(k) clearance?

USA SERIES LAPAROSCOPES received FDA 510(k) clearance on 2002-01-18, under 510(k) number K013165.

Who is the listed applicant for USA SERIES LAPAROSCOPES?

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

What is the FDA product code for USA SERIES LAPAROSCOPES?

The FDA product code for USA SERIES LAPAROSCOPES is GCJ.

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Other records listing Circon Acmi as applicant

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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Related Devices (Code: GCJ)

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

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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