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510(k) K242610

8mm Monopolar Curved Scissors (470179) by Iconocare Health — Product Code QSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2025
Date Received
September 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Surgical, Computer Controlled Instrument, Remanufactured
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

As intended with the originally cleared instrument.

Other clearances by Iconocare Health

  • K210478 — 8mm Monopolar Curved Scissors (September 30, 2022)

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  • K241872 — Remanufactured EndoWrist ProGrasp Forceps (420093) (November 7, 2024)
  • K210478 — 8mm Monopolar Curved Scissors (September 30, 2022)