510(k) · Cleared
ClearedSERFAS 90-S Electrosurgical Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 3, 2016 as substantially equivalent to K041810 (Stryker Endoscopy, 2004) after a 113-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- May 3, 2016
- Review
- 113 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011083 (2001). 17 ancestors in all, the oldest K974022 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 6 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 5 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 4 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 3 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 2 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 1 generation backK041810 Serfas Energy SystemStryker Endoscopy · 2004 · Recalled
- This deviceK160050 SERFAS 90-S Electrosurgical ProbeStryker Corporation · 2016
- Descendant · cites it directly · 0 of its ownK171391 Stryker 90-S Max SERFAS Energy ProbeStryker · 2018
Most influential descendants
Showing 1 of 1 · See all- K171391Stryker 90-S Max SERFAS Energy ProbeStryker · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −6 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −5 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −3 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −2 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −1 | K041810 | Serfas Energy System | Stryker Endoscopy | 2004 | 3 |
| 0 (this device) | K160050 | SERFAS 90-S Electrosurgical Probe | Stryker Corporation | 2016 | — |
| +1 | K171391 | Stryker 90-S Max SERFAS Energy Probe | Stryker | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K041810 | Serfas Energy SystemSummary page 4…y*) Common Name RF System, RF Generator, RF Probe, RF Footswitch Premarket Notification K041810 Classification Name Electrosurgical Cutting and Coagulation Device and… | 2004 |
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 |
|---|---|---|---|
| K171391 | Stryker 90-S Max SERFAS Energy Probe | 2018 | 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K171391 (Stryker, 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K041810.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Stryker SERFAS 90-S Electrosurgical Probe is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.
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/K160050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160050: SERFAS 90-S 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/K160050
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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