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KARL STORZ HOPKINS Telescopes for Urology

by Karl Storz SE & CO. KG

510(k) K243653

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) K243653↗

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 NumberK243653 Date13 Aug 2025ClearedStatusActive
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  • Withdrawn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
FAJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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 Karl Storz Hopkins Telescopes for Urology are rigid cystoscopes and associated accessories, designed for endoscopic visualization in urological procedures. These telescopes provide high-resolution imaging through flexible or rigid insertion, enabling diagnostic and therapeutic interventions in both adult and pediatric patients.

These devices are intended for use in sterile environments during urological procedures, supplied as single-use or reusable instruments depending on the model. They are classified as Class II medical devices under FDA regulations and comply with MDR standards. Telescopes are available in various diameters, including 4mm, and may be combined with sheaths, obturators, and other accessories for enhanced functionality. Storage and handling follow manufacturer guidelines to maintain sterility and performance.

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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.

  • Are the Karl Storz Hopkins Telescopes for Urology available in single-use or reusable options, and how should I determine which to choose for my procedure?

    The Karl Storz Hopkins Telescopes for Urology come in both single-use and reusable models, depending on the specific variant. The choice depends on your facility’s infection control protocols and procedural needs. Single-use telescopes eliminate reprocessing risks and are ideal for sterile, one-time procedures, while reusable models may be cost-effective for high-volume settings if properly sterilized per manufacturer guidelines. Always verify the model’s intended use in the packaging or consult Karl Storz’s technical documentation.

  • What diameters are available for the Karl Storz Hopkins Telescopes for Urology, and how might this affect my choice for pediatric vs. adult patients?

    The telescopes are available in various diameters, including at least a 4mm variant, though exact sizes may vary by model. Smaller diameters (e.g., 4mm) are typically better suited for pediatric patients due to reduced tissue trauma and easier navigation through narrower anatomical pathways. For adults, larger diameters may offer improved image quality or stability. Check the specific model’s documentation to confirm compatibility with your patient population.

  • How should I store these telescopes to maintain their performance and sterility, especially if they are reusable?

    Storage and handling follow Karl Storz’s guidelines to preserve sterility and functionality. Reusable telescopes must be cleaned, disinfected, and sterilized per the manufacturer’s instructions before storage in a clean, dry environment. Single-use models should remain in their sealed packaging until use. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these can degrade optics or materials. Always refer to the included instructions for storage conditions specific to your model.

  • What regulatory pathways have these telescopes undergone, and how does this affect their use in clinical settings?

    The Karl Storz Hopkins Telescopes for Urology have undergone FDA 510(k) clearance and comply with MDR (Medical Device Regulation) standards, confirming their safety and performance for intended use. This means they meet regulatory requirements for marketing in the U.S. and EU, respectively. Clinically, this ensures they’ve been evaluated for risks and benefits in urological procedures, but always verify the specific model’s approvals and follow local regulatory guidelines for procurement and use.