510(k) · Cleared
Recalled · Class II · 2019Stryker Strykeflow Electrocautery Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 31, 1997 as substantially equivalent to K934094 (Stryker Corp., 1994) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 31, 1997
- Review
- 134 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934094 (1994). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK934094 Stryker Laparoscopic Suction IrrigatorStryker Corp. · 1994 · Recalled
- This deviceK963765 Stryker Strykeflow Electrocautery ProbesStryker Endoscopy · 1997
- Descendant · cites it directly · 1 of its ownK100711 Suction Irrigation Electrodes and AdaptersEncision, Inc. · 2010 · Recalled
- Descendant · cites it directly · 1 of its ownK052141 Stryker Stiletto Electrosurgical ProbeStryker Endoscopy · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK190168 Aquas ProbesGenicon, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK131949 Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK102275 Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220…Thermedx, LLC · 2011
Most influential descendants
Showing 5 of 5 · See all- K100711Suction Irrigation Electrodes and AdaptersEncision, Inc. · 2010 · cites it directly1descendant
- K052141Stryker Stiletto Electrosurgical ProbeStryker Endoscopy · 2005 · cites it directly1descendant
- K190168Aquas ProbesGenicon, Inc. · 2019 · 2 generations on0descendants
- K131949Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013 · 2 generations on0descendants
- K102275Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240Thermedx, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934094 | Stryker Laparoscopic Suction Irrigator | Stryker Corp. | 1994 | 3 |
| 0 (this device) | K963765 | Stryker Strykeflow Electrocautery Probes | Stryker Endoscopy | 1997 | — |
| +1 | K100711 | Suction Irrigation Electrodes and Adapters | Encision, Inc. | 2010 | 5 |
| +1 | K052141 | Stryker Stiletto Electrosurgical Probe | Stryker Endoscopy | 2005 | 3 |
| +2 | K190168 | Aquas Probes | Genicon, Inc. | 2019 | — |
| +2 | K131949 | Aem Disposable Suction Irrigation Electrodes | Encision, Inc. | 2013 | — |
| +1 | K102275 | Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230… | Thermedx, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K934094 | Stryker Laparoscopic Suction IrrigatorSummary page 1…ns of electrocautery cutting and coagulation along with suction and irrigation in the same tool when used in combination with the Stryker Strykeflow Suction / Irrigator (K934094 and K954726). The Electrocautery Probe includes a variety of tip configurations for those laparoscopic surgical procedures where… | 1994 |
| * | K954726 | Stryker Strykeflow Suction Irrigator (Modification)Summary page 1…ocautery cutting and coagulation along with suction and irrigation in the same tool when used in combination with the Stryker Strykeflow Suction / Irrigator (K934094 and K954726). The Electrocautery Probe includes a variety of tip configurations for those laparoscopic surgical procedures where the delivery… | 1995 |
| * | — | Valleylab Laparoscopic Handswitch/Electrodes Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2019 | Class II | Z-1508-2020 | Other | Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This… |
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.
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 Electrocautery Probe includes a variety of tip configurations for those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single probe is desirable.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963765 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963765: Stryker Strykeflow Electrocautery Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963765
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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