510(k) · Cleared
Recalled · 2010Stryker Stiletto Electrosurgical Probe
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 Oct 6, 2005 as substantially equivalent to K963765 (Stryker Endoscopy, 1997) after a 59-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 6, 2005
- Review
- 59 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934094 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK934094 Stryker Laparoscopic Suction IrrigatorStryker Corp. · 1994 · Recalled
- 1 generation backK963765 Stryker Strykeflow Electrocautery ProbesStryker Endoscopy · 1997 · Recalled
- This deviceK052141 Stryker Stiletto Electrosurgical ProbeStryker Endoscopy · 2005
- Descendant · cites it directly · 0 of its ownK190168 Aquas ProbesGenicon, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190168Aquas ProbesGenicon, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934094 | Stryker Laparoscopic Suction Irrigator | Stryker Corp. | 1994 | 3 |
| −1 | K963765 | Stryker Strykeflow Electrocautery Probes | Stryker Endoscopy | 1997 | 1 |
| 0 (this device) | K052141 | Stryker Stiletto Electrosurgical Probe | Stryker Endoscopy | 2005 | — |
| +1 | K190168 | Aquas Probes | Genicon, Inc. | 2019 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K963765 | Stryker Strykeflow Electrocautery ProbesSummary page 1…trosurgical Probe is substantially equivalent in terms of safety and effectiveness to currently marketed devices, including the Stryker Strykeflow Electrocautery Probes (K963765). The Stryker Stiletto Electrosurgical Probe is a new product developed by Stryker. The Stryker Stiletto Electrosurgical Probe is… | 1997 |
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 |
|---|---|---|---|
| K190168 | Aquas Probes | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2010 | Not classified | Z-1704-2011 | Device Design | The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%). |
| Nov 16, 2007 | Not classified | Z-0573-2008 | Device Design | Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable. |
| Nov 16, 2007 | Not classified | Z-0574-2008 | Device Design | Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K190168 (Genicon, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K963765.
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 Stryker Stiletto Electrosurgical Probe is indicated for use in laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, laparoscopic thoracic surgery, gynecological surgery, general surgery and urological surgery. The device allows for suction and irrigation of sterile irrigant solution. In addition, the device is intended to be used for electrosurgical cutting/coagulation during laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052141: Stryker Stiletto Electrosurgical Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052141
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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