Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HSW GMBH ARTHROSCOPE

K-Number: K962075 · 1997-01-17

ApplicantHenke Sass Wolf of America, Inc.
Decision Date1997-01-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HSW GMBH 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 1997-01-17 under 510(k) number K962075. 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 HSW GMBH ARTHROSCOPE?

HSW GMBH ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Henke Sass Wolf of America, Inc.. The 510(k) number is K962075.

When did HSW GMBH ARTHROSCOPE receive FDA 510(k) clearance?

HSW GMBH ARTHROSCOPE received FDA 510(k) clearance on 1997-01-17, under 510(k) number K962075.

Who is the listed applicant for HSW GMBH 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 HSW GMBH ARTHROSCOPE?

The FDA product code for HSW GMBH ARTHROSCOPE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEK050163HENKE 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-JECT

View all 9 devices →

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.

↑