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510(k) K120567

GYRUS AMCI PK BUTTON ELECTRODE by Gyrus Acmi, Inc. — Product Code FAS

K120567 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "GYRUS AMCI PK BUTTON ELECTRODE". The FDA issued a decision of Substantially Equivalent on June 20, 2012. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2012
Date Received
February 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Gyrus Acmi, Inc.

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  • K231327 — POWERSEAL Sealer and Divider (October 25, 2023)
  • K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperP (January 27, 2023)
  • K212650 — Celeris, Disposable Sinus Debrider (January 19, 2022)
  • K213831 — Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (January 4, 2022)
  • K211401 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed (June 3, 2021)
  • K181696 — ChitoZolve (November 30, 2018)
  • K180086 — Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (March 8, 2018)
  • K171440 — Berkeley VC-10 Vacuum Curettage System (September 29, 2017)

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)
  • K163090 — Plasma Edge System (May 23, 2017)
  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K152092 — Resection Electrodes (October 26, 2015)

FDA data resources