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FDA 510(k)

CORTEK MINI LAPAROSCOPE

K-Number: K000199 · 2000-04-13

ApplicantCortek Endoscopy, Inc.
Decision Date2000-04-13
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CORTEK MINI LAPAROSCOPE 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 2000-04-13 under 510(k) number K000199. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTEK MINI LAPAROSCOPE?

CORTEK MINI LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 2000-04-13. The listed applicant is Cortek Endoscopy, Inc.. The 510(k) number is K000199.

When did CORTEK MINI LAPAROSCOPE receive FDA 510(k) clearance?

CORTEK MINI LAPAROSCOPE received FDA 510(k) clearance on 2000-04-13, under 510(k) number K000199.

Who is the listed applicant for CORTEK MINI LAPAROSCOPE?

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 MINI LAPAROSCOPE?

The FDA product code for CORTEK MINI LAPAROSCOPE is HET.

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.

K000198CORTEK ARTHROSCOPEK000202CORTEK LAPAROSCOPESK000200CORTEK URETHEROSCOPEK000197CORTEK CYSTOSCOPE

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

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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