# K233425: FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)

- Pathway: 510(k) (Traditional)
- Applicant: Sutter Medizintechnik GmbH
- Decided: Jan 25, 2024 after 106 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003126 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170377: TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM, Richard Wolf Medical Instruments Corporation (2017) Summary page 6.

## Indications for use
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radiofrequency current. The products are intended for use in endoscopically performed or supported surgeries. The types of surgery intended are: • Endoscopic procedures • Orthopedic procedures • Neurosurgical coagulation

Source page: https://510kreport.com/device/K233425
Methodology: https://510kreport.com/methodology