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FDA 510(k)

SOPRO 670 ARTHROSCOPIC PUMP

K-Number: K080122 · 2008-07-11

ApplicantSopro
Decision Date2008-07-11
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOPRO 670 ARTHROSCOPIC PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2008-07-11 under 510(k) number K080122. 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 SOPRO 670 ARTHROSCOPIC PUMP?

SOPRO 670 ARTHROSCOPIC PUMP is a medical device that received FDA 510(k) clearance on 2008-07-11. The listed applicant is Sopro. The 510(k) number is K080122.

When did SOPRO 670 ARTHROSCOPIC PUMP receive FDA 510(k) clearance?

SOPRO 670 ARTHROSCOPIC PUMP received FDA 510(k) clearance on 2008-07-11, under 510(k) number K080122.

Who is the listed applicant for SOPRO 670 ARTHROSCOPIC PUMP?

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

What is the FDA product code for SOPRO 670 ARTHROSCOPIC PUMP?

The FDA product code for SOPRO 670 ARTHROSCOPIC PUMP is HRX.

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Other records listing Sopro 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.

K223470C50K121685SOPROCAREK103813SOPRO 281K092329SOPIX 2K092583SOPROLIFEK082796SOPRO 184 CAMERA

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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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