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510(k) K251813

CURIS II RF Generator (REF 360100-05) by Sutter Medizintechnik GmbH — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2026
Date Received
June 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Sutter Medizintechnik GmbH

  • K233425 — FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrode (January 25, 2024)
  • K193587 — Sutter Swyng non-stick bipolar forceps, single-use (February 10, 2020)
  • K192128 — Sutter Arrowtip Monopolar Electrodes (October 4, 2019)
  • K191732 — Sutter RaVoR Bipolar Electrodes (August 30, 2019)
  • K171869 — Sutter CURIS RF Generator (February 23, 2018)
  • K150959 — Sutter Bipolar Forceps-Calvian (September 10, 2015)
  • K131012 — SUTTER BIPOLAR FORCEPS - SUPERGLISS (August 23, 2013)
  • K073450 — SUTTER ELECTROSURGICAL CABLES (March 17, 2008)

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  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
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  • K253915 — MOVIVA® Hybrid Ablation Probe (December 18, 2025)