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510(k) K221672

Creo Electrosurgical System with NP1 Instrument by Creo Medical, Ltd. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2023
Date Received
June 9, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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  • K192905 — Creo Electrosurgical System with HS1 Hemostasis Accessory (March 19, 2020)
  • K171983 — Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory (August 17, 2017)

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