FDA 510(k)

KARL STORZ HOPKINS Telescopes for Urology

Numéro K : K243653 · 2025-08-13

Date de décision2025-08-13

Code produitFAJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

KARL STORZ HOPKINS Telescopes for Urology is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K243653. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the KARL STORZ HOPKINS Telescopes for Urology?

KARL STORZ HOPKINS Telescopes for Urology is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K243653.

When did KARL STORZ HOPKINS Telescopes for Urology receive FDA 510(k) clearance?

KARL STORZ HOPKINS Telescopes for Urology received FDA 510(k) clearance on 2025-08-13, under 510(k) number K243653.

Who is the listed applicant for KARL STORZ HOPKINS Telescopes for Urology?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ HOPKINS Telescopes for Urology?

The FDA product code for KARL STORZ HOPKINS Telescopes for Urology is FAJ.

Essais cliniques associés

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Autres dossiers indiquant Karl Storz SE & CO. KG en tant que demandeur

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)K254303KARL STORZ SUPRALOOP K261102UNIDRIVE Select System K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)K260884UNIDRIVE Select System K254103HOPKINS Telescopes for Arthroscopy

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Dispositifs connexes (Code : FAJ)

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Source officielle

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