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FDA 510(k)

HENKE SASS WOLF OF AMERICA ARTHROSCOPE

K-Number: K080560 · 2008-03-18

ApplicantHenke Sass Wolf of America, Inc.
Decision Date2008-03-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HENKE SASS WOLF OF AMERICA ARTHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Henke Sass Wolf of America, Inc.. It received FDA 510(k) clearance on 2008-03-18 under 510(k) number K080560. 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 HENKE SASS WOLF OF AMERICA ARTHROSCOPE?

HENKE SASS WOLF OF AMERICA ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 2008-03-18. The listed applicant is Henke Sass Wolf of America, Inc.. The 510(k) number is K080560.

When did HENKE SASS WOLF OF AMERICA ARTHROSCOPE receive FDA 510(k) clearance?

HENKE SASS WOLF OF AMERICA ARTHROSCOPE received FDA 510(k) clearance on 2008-03-18, under 510(k) number K080560.

Who is the listed applicant for HENKE SASS WOLF OF AMERICA ARTHROSCOPE?

The FDA 510(k) record lists Henke Sass Wolf of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HENKE SASS WOLF OF AMERICA ARTHROSCOPE?

The FDA product code for HENKE SASS WOLF OF AMERICA ARTHROSCOPE is HRX.

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Other records listing Henke Sass Wolf of America, 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.

K050163HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPEK030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPEK013611HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPEK991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, CK983067FINE-JECTK981751SINUSCOPE AND ACCESSORIES

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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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