FDA 510(k) K242610, 8mm Monopolar Curved Scissors (470179), by Iconocare Health
FDA 510(k) K242610, 8mm Monopolar Curved Scissors (470179), by Iconocare Health
Device Classification Name: System, Surgical, Computer Controlled Instrument, Remanufactured
510(k) Number: K242610
Device Name: 8mm Monopolar Curved Scissors (470179)
Applicant: Iconocare Health
Regulation Number: 876.1500
Classification Product Code: QSM
Date Received: 09/03/2024
Decision Date: 03/11/2025
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: General & Plastic Surgery
Total number of pages: 3,430
Fully redacted pages: 793
Content pages: 2,637
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