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FDA 510(k)

X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM

K-Number: K041824 · 2005-01-07

ApplicantFuture Medical Systems, SA
Decision Date2005-01-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Future Medical Systems, SA. It received FDA 510(k) clearance on 2005-01-07 under 510(k) number K041824. 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 X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM?

X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-01-07. The listed applicant is Future Medical Systems, SA. The 510(k) number is K041824.

When did X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM receive FDA 510(k) clearance?

X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM received FDA 510(k) clearance on 2005-01-07, under 510(k) number K041824.

Who is the listed applicant for X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM?

The FDA 510(k) record lists Future Medical Systems, SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM?

The FDA product code for X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM 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 Future Medical Systems, SA 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.

K024185BIODHOC

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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