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HSW GmbH Arthroscope

by Henke Sass Wolf of America, Inc.

510(k) K962075

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K962075↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK962075 Date17 Jan 1997ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The HSW GmbH Arthroscope is an endoscopic device used for arthroscopy procedures. It provides excellent imaging properties to assist surgeons in making accurate diagnoses and achieving optimal therapeutic results.

This device is supplied by Henke Sass Wolf of America, Inc. and is available in various models. It has received FDA 510(k) clearance with the product code HRX and is intended for use in orthopedic procedures.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HSW GmbH Arthroscope used for?

    The HSW GmbH Arthroscope is an endoscopic device used for arthroscopy procedures to provide excellent imaging properties that assist surgeons in making accurate diagnoses and achieving optimal therapeutic results in orthopedic procedures.

  • What models of the HSW GmbH Arthroscope are available?

    The device is available in various models, though specific model details are not provided in the device data. Henke Sass Wolf of America, Inc. supplies these different models of the arthroscope.

  • What regulatory approvals does the HSW GmbH Arthroscope have?

    The HSW GmbH Arthroscope has received FDA 510(k) clearance with the product code HRX and is also listed under MDR (Medical Device Reporting) requirements. It was determined to be substantially equivalent through a traditional clearance process.

  • Who manufactures the HSW GmbH Arthroscope?

    The HSW GmbH Arthroscope is manufactured by Henke Sass Wolf of America, Inc., located at Soroco Industrial Park, Rte. 131, Southbridge, MA 01550, with John M Smith as the contact person.