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510(k) K210478

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2022
Date Received
February 19, 2021
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

  • K242610 — 8mm Monopolar Curved Scissors (470179) (March 11, 2025)

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  • K250539 — Remanufactured EndoWrist Tenaculum Forceps (420207) (August 19, 2025)
  • K242610 — 8mm Monopolar Curved Scissors (470179) (March 11, 2025)
  • K241872 — Remanufactured EndoWrist ProGrasp Forceps (420093) (November 7, 2024)