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FDA 510(k)

LAPAROSCOPIC HAND PORT

K-Number: K003871 · 2001-05-31

ApplicantApplied Medical Resources Corp.
Decision Date2001-05-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC HAND PORT is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2001-05-31 under 510(k) number K003871. 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 LAPAROSCOPIC HAND PORT?

LAPAROSCOPIC HAND PORT is a medical device that received FDA 510(k) clearance on 2001-05-31. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K003871.

When did LAPAROSCOPIC HAND PORT receive FDA 510(k) clearance?

LAPAROSCOPIC HAND PORT received FDA 510(k) clearance on 2001-05-31, under 510(k) number K003871.

Who is the listed applicant for LAPAROSCOPIC HAND PORT?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROSCOPIC HAND PORT?

The FDA product code for LAPAROSCOPIC HAND PORT is GCJ.

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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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