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FDA 510(k)

ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE

K-Number: K083707 · 2009-08-03

ApplicantArthrex, Inc.
Decision Date2009-08-03
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2009-08-03 under 510(k) number K083707. 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 ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE?

ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE is a medical device that received FDA 510(k) clearance on 2009-08-03. The listed applicant is Arthrex, Inc.. The 510(k) number is K083707.

When did ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE receive FDA 510(k) clearance?

ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE received FDA 510(k) clearance on 2009-08-03, under 510(k) number K083707.

Who is the listed applicant for ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE?

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

What is the FDA product code for ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE?

The FDA product code for ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE is HRX.

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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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