FDA 510(k)

Système de scope chirurgical AURORA® (ASX15/60); Système de scope chirurgical AURORA® (ASX15/80)

Numéro K : K250752 · 2025-04-09

DemandeurIntegra LifeSciences Corporation

Date de décision2025-04-09

Code produitGWG

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K250752. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)?

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K250752.

When did AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) receive FDA 510(k) clearance?

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) received FDA 510(k) clearance on 2025-04-09, under 510(k) number K250752.

Who is the listed applicant for AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)?

The FDA product code for AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) is GWG.

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Source officielle

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