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FDA 510(k)

CORTEK ARTHROSCOPE

K-Number: K000198 · 2000-04-11

ApplicantCortek Endoscopy, Inc.
Decision Date2000-04-11
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORTEK ARTHROSCOPE 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 2000-04-11 under 510(k) number K000198. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTEK ARTHROSCOPE?

CORTEK ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 2000-04-11. The listed applicant is Cortek Endoscopy, Inc.. The 510(k) number is K000198.

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

CORTEK ARTHROSCOPE received FDA 510(k) clearance on 2000-04-11, under 510(k) number K000198.

Who is the listed applicant for CORTEK ARTHROSCOPE?

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 ARTHROSCOPE?

The FDA product code for CORTEK ARTHROSCOPE is HRX.

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 LAPAROSCOPEK000202CORTEK LAPAROSCOPESK000200CORTEK URETHEROSCOPEK000197CORTEK CYSTOSCOPE

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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