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FDA 510(k)

POWERPUMP ARTHROSCOPY SYSTEM

K-Number: K093409 · 2010-02-24

Decision Date2010-02-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POWERPUMP ARTHROSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Vision AB. It received FDA 510(k) clearance on 2010-02-24 under 510(k) number K093409. 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 POWERPUMP ARTHROSCOPY SYSTEM?

POWERPUMP ARTHROSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-24. The listed applicant is Medical Vision AB. The 510(k) number is K093409.

When did POWERPUMP ARTHROSCOPY SYSTEM receive FDA 510(k) clearance?

POWERPUMP ARTHROSCOPY SYSTEM received FDA 510(k) clearance on 2010-02-24, under 510(k) number K093409.

Who is the listed applicant for POWERPUMP ARTHROSCOPY SYSTEM?

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

What is the FDA product code for POWERPUMP ARTHROSCOPY SYSTEM?

The FDA product code for POWERPUMP ARTHROSCOPY 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.

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.

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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