510(k) · Cleared
Recalled · Class II · 2015Serfas Energy System
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 Dec 21, 2004 as substantially equivalent to K991960 (Stryker Endoscopy, 1999) and 10 other predicates after a 168-day review. Its family tree reaches back 6 generations to 2001. 17 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 21, 2004
- Review
- 168 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3
- Predicates
- 11
Its longest line of descent runs back 6 generations to K011083 (2001). 16 ancestors in all, the oldest K974022 (1998). 17 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 5 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 4 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 3 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 2 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 1 generation backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- This deviceK041810 Serfas Energy SystemStryker Endoscopy · 2004
- Descendant · cites it directly · 7 of its ownK113545 Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II…Depuy Mitek, A Johnson & Johnson Company · 2012
- Descendant · cites it directly · 4 of its ownK071859 Stryker Crossfire SystemStryker Endoscopy · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK162770 Relign SystemRelign Corporation · 2017
- Descendant · 3 generations on · 2 of its ownK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
2007high 3 (2016) · low 0 (2008)2026
Most influential descendants
Showing 5 of 17 · See all- K113545Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System…Depuy Mitek, A Johnson & Johnson Company · 2012 · cites it directly7descendants
- K071859Stryker Crossfire SystemStryker Endoscopy · 2007 · cites it directly4descendants
- K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · 2 generations on3descendants
- K162770Relign SystemRelign Corporation · 2017 · 2 generations on2descendants
- K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −5 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −4 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −3 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −2 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −1 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| 0 (this device) | K041810 | Serfas Energy System | Stryker Endoscopy | 2004 | — |
| +1 | K113545 | Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical… | Depuy Mitek, A Johnson & Johnson Company | 2012 | — |
| +1 | K071859 | Stryker Crossfire System | Stryker Endoscopy | 2007 | 2 |
| +2 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
| +2 | K162770 | Relign System | Relign Corporation | 2017 | — |
| +3 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating… | Bovie Medical Corporation | 2016 | 3 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (11)
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 |
|---|---|---|---|
| * | K991960 | Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas…Summary page 1…edures of joints such as the knee, shoulder, elbow, hip, ankle and wrist. Predicate Devices Stryker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K03055… | 1999 |
| * | K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000…Summary page 1…shoulder, elbow, hip, ankle and wrist. Predicate Devices Stryker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR Syste… | 2000 |
| * | K011634 | Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model…Summary page 1…er, elbow, hip, ankle and wrist. Predicate Devices Stryker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K97402… | 2001 |
| * | K020832 | Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, WandsSummary page 1…, hip, ankle and wrist. Predicate Devices Stryker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022 S… | 2002 |
| * | K032504 | Arthrocare SystemSummary page 1…kle and wrist. Predicate Devices Stryker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022 Substantia… | 2003 |
| * | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare ArthrowandSummary page 1…Stryker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022 Substantial Equivalence When compared to the pr… | 2001 |
| * | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma WandSummary page 1…yker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022 Substantial Equivalence When compared to the predicated… | 2001 |
| * | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsSummary page 1…scopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022 Substantial Equivalence When compared to the predicated devices l… | 2002 |
| * | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control…Summary page 1…io Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022 Substantial Equivalence When compared to the predicated devices listed abo… | 2003 |
| * | K033584 | Arthrocare ArthrowandsSummary page 1…ncy Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022 Substantial Equivalence When compared to the predicated devices listed above the SE… | 2003 |
| * | K974022 | VAPRSummary page 1…0 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022 Substantial Equivalence When compared to the predicated devices listed above the SERFAS Energy System has the same… | 1998 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113545 | Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System… | 2012 | 7 |
| K071859 | Stryker Crossfire System | 2007 | 4 |
| K160050 | SERFAS 90-S Electrosurgical Probe | 2016 | 1 |
| K172608 | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes | 2017 | 0 |
| K121855 | Resprocessed Serfas Energy Probe | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2015 | Class II | Z-1831-2015 | Device Design | Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient. |
| Jun 20, 2008 | Not classified | Z-0972-2009 | Process control | The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area. |
| Apr 26, 2007 | Not classified | Z-0484-2008 | Mixed-up of materials/components | Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K113545 (Depuy Mitek, A Johnson & Johnson Company, 2012) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K991960.
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
2007high 65 (2023) · low 35 (2011)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
2007high 183 (2026) · low 51 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
2007high 51 (2010) · low 1 (2020)2026
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
2007high 7,897 (2024) · low 2,556 (2008)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 SERFAS Energy System 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 as stated in the FDA summary.
https://510kreport.com/device/K041810 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041810: Serfas Energy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041810
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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