510(k) · Cleared
ClearedFlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sutter Medizintechnik GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 25, 2024 as substantially equivalent to K170377 (Richard Wolf Medical Instruments Corporation, 2017) after a 106-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 25, 2024
- Review
- 106 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003126 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK003126 Bipolar Trigger-Flex ProbeEllman Intl., Inc. · 2001
- 1 generation backK170377 TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF…Richard Wolf Medical Instruments Corporation · 2017
- This deviceK233425 FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip…Sutter Medizintechnik GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003126 | Bipolar Trigger-Flex Probe | Ellman Intl., Inc. | 2001 | — |
| −1 | K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO… | Richard Wolf Medical Instruments Corporation | 2017 | — |
| 0 (this device) | K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar… | Sutter Medizintechnik GmbH | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL…Summary page 6…n Panel: General & Plastic Surgery Regulatory Class: II Product Code: GEI 510k #: TBD IV PREDICATE DEVICE K170377 – TipControl RF Instrument, bipo Page 2 of 9 V. DEVICE DESCRIPTION Fle… | 2017 |
| † | K171869 | Sutter CURIS RF Generator | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 16.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233425: FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233425
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026