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FDA 510(k)

OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES

K-Number: K945267 · 1995-05-23

ApplicantOptus, Inc.
Decision Date1995-05-23
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Optus, Inc.. It received FDA 510(k) clearance on 1995-05-23 under 510(k) number K945267. 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 OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES?

OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES is a medical device that received FDA 510(k) clearance on 1995-05-23. The listed applicant is Optus, Inc.. The 510(k) number is K945267.

When did OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES receive FDA 510(k) clearance?

OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES received FDA 510(k) clearance on 1995-05-23, under 510(k) number K945267.

Who is the listed applicant for OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES?

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

What is the FDA product code for OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES?

The FDA product code for OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES is HRX.

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Other records listing Optus, 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.

K945264OPTUS OTOSCOPESK953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESK945268OPTUS BRONCHOSCOPESK945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESK945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESK945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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