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FDA 510(k)

MARKOPTIC IMPROVED ARTHROSCOPE

K-Number: K860607 · 1986-03-05

ApplicantMarkoptic
Decision Date1986-03-05
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MARKOPTIC IMPROVED ARTHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Markoptic. It received FDA 510(k) clearance on 1986-03-05 under 510(k) number K860607. 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 MARKOPTIC IMPROVED ARTHROSCOPE?

MARKOPTIC IMPROVED ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 1986-03-05. The listed applicant is Markoptic. The 510(k) number is K860607.

When did MARKOPTIC IMPROVED ARTHROSCOPE receive FDA 510(k) clearance?

MARKOPTIC IMPROVED ARTHROSCOPE received FDA 510(k) clearance on 1986-03-05, under 510(k) number K860607.

Who is the listed applicant for MARKOPTIC IMPROVED ARTHROSCOPE?

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

What is the FDA product code for MARKOPTIC IMPROVED ARTHROSCOPE?

The FDA product code for MARKOPTIC IMPROVED 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 Markoptic 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.

K830120IMPROVED ARTHROSCOPE

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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