Home / 510(k) Clearances / K233425

510(k) K233425

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) by Sutter Medizintechnik GmbH — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2024
Date Received
October 11, 2023
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

  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • 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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