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FDA 510(k)

APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE

K-Number: K014047 · 2002-02-28

Decision Date2002-02-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE 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 2002-02-28 under 510(k) number K014047. 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 APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE?

APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2002-02-28. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K014047.

When did APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE receive FDA 510(k) clearance?

APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE received FDA 510(k) clearance on 2002-02-28, under 510(k) number K014047.

Who is the listed applicant for APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE?

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 APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE?

The FDA product code for APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE is GCJ.

Related Clinical Trials

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.

Other records listing Applied Medical Resources Corp. 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.

View all 43 devices →

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.

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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