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FDA 510(k)

CORTEK LAPAROSCOPES

K-Number: K000202 · 2000-03-31

ApplicantCortek Endoscopy, Inc.
Decision Date2000-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORTEK LAPAROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Cortek Endoscopy, Inc.. It received FDA 510(k) clearance on 2000-03-31 under 510(k) number K000202. 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 CORTEK LAPAROSCOPES?

CORTEK LAPAROSCOPES is a medical device that received FDA 510(k) clearance on 2000-03-31. The listed applicant is Cortek Endoscopy, Inc.. The 510(k) number is K000202.

When did CORTEK LAPAROSCOPES receive FDA 510(k) clearance?

CORTEK LAPAROSCOPES received FDA 510(k) clearance on 2000-03-31, under 510(k) number K000202.

Who is the listed applicant for CORTEK LAPAROSCOPES?

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

What is the FDA product code for CORTEK LAPAROSCOPES?

The FDA product code for CORTEK LAPAROSCOPES 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.

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Other records listing Cortek Endoscopy, Inc. 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.

K000199CORTEK MINI LAPAROSCOPEK000198CORTEK ARTHROSCOPEK000200CORTEK URETHEROSCOPEK000197CORTEK CYSTOSCOPE

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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