510(k) · Cleared
ClearedTipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 5, 2017 as substantially equivalent to K003126 (Ellman Intl., Inc., 2001) after a 57-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Apr 5, 2017
- Review
- 57 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003126 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003126 Bipolar Trigger-Flex ProbeEllman Intl., Inc. · 2001
- This deviceK170377 TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF…Richard Wolf Medical Instruments Corporation · 2017
- Descendant · cites it directly · 0 of its ownK233425 FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip…Sutter Medizintechnik GmbH · 2024
Most influential descendants
Showing 1 of 1 · See all- K233425FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes…Sutter Medizintechnik GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003126 | Bipolar Trigger-Flex Probe | Ellman Intl., Inc. | 2001 | — |
| 0 (this device) | K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO… | Richard Wolf Medical Instruments Corporation | 2017 | — |
| +1 | K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar… | Sutter Medizintechnik GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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 |
|---|---|---|---|
| * | K003126 | Bipolar Trigger-Flex ProbeSummary page 4…and accessories. Information on devices to which substantial equivalence is claimed: 510(k) No.: Trade or proprietary or model name: Manufacturer: K003126 Trigger Flex™ Bipolar Electrode ELLMAN INTL., INC. 5. 510(k) Summary 1 of… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes… | 2024 | 0 |
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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 radio-frequency current.
The products are intended for use in endoscopically performed or supported surgeries. The types of surgery intended are:
* Endoscopic procedures
* Orthopedic coagulation
* Neurosurgical coagulation
The products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170377: TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170377
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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