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FDA 510(k)

ARTHROSCOPE

K-Number: K944842 · 1995-01-24

Applicant5 Star Medical, Inc.
Decision Date1995-01-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is 5 Star Medical, Inc.. It received FDA 510(k) clearance on 1995-01-24 under 510(k) number K944842. 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 ARTHROSCOPE?

ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is 5 Star Medical, Inc.. The 510(k) number is K944842.

When did ARTHROSCOPE receive FDA 510(k) clearance?

ARTHROSCOPE received FDA 510(k) clearance on 1995-01-24, under 510(k) number K944842.

Who is the listed applicant for ARTHROSCOPE?

The FDA 510(k) record lists 5 Star Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHROSCOPE?

The FDA product code for 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing 5 Star Medical, 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.

K083645RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS

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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