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510(k) K163090

Plasma Edge System by Chirurgie Innovation — Product Code FAS

K163090 is an FDA 510(k) premarket notification submitted by Chirurgie Innovation for the device "Plasma Edge System". The FDA issued a decision of Substantially Equivalent on May 23, 2017. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Chirurgie Innovation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2017
Date Received
November 4, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Chirurgie Innovation

  • K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, (March 2, 2022)

Other clearances for product code FAS

  • K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Elect (December 5, 2025)
  • K250522 — Multi4 System (June 27, 2025)
  • K240504 — PLASMA EDGE System (June 12, 2024)
  • K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, (March 2, 2022)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K210394 — Electrosurgical accessory (May 19, 2021)
  • K171965 — Resection Electrodes with HF cable (September 28, 2017)
  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K152092 — Resection Electrodes (October 26, 2015)
  • K120567 — GYRUS AMCI PK BUTTON ELECTRODE (June 20, 2012)

FDA data resources