510(k) · Cleared
ClearedStryker RF Parallel Bipolar Adaptor Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 10, 2006 as substantially equivalent to K043442 (Stryker Instruments, 2005) and 4 other predicates after a 119-day review. Its family tree reaches back 3 generations to 1999. 5 later devices descend from it.
- Decided
- Oct 10, 2006
- Review
- 119 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K991218 (1999). 13 ancestors in all, the oldest K896450 (1991). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
- 2 generations backK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
- 1 generation backK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- This deviceK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
- Descendant · cites it directly · 4 of its ownK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK241621 Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024
- Descendant · 3 generations on · 0 of its ownK143662 Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK133167 Monopolar Cautery Cord, Bipolar Cautery CordIntuitive Surgical, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K083528Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009 · cites it directly4descendants
- K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…Olsen Medical · 2012 · 2 generations on3descendants
- K241621Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024 · 3 generations on0descendants
- K143662Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015 · 3 generations on0descendants
- K133167Monopolar Cautery Cord, Bipolar Cautery CordIntuitive Surgical, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991218 | Oratec Bipolar Ablation Probes | Oratec Interventions, Inc. | 1999 | — |
| −2 | K031371 | Saphyre Bipolar Ablation Probes | Smith & Nephew, Inc. | 2003 | — |
| −1 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| 0 (this device) | K061660 | Stryker RF Parallel Bipolar Adaptor Cable | Stryker Instruments | 2006 | — |
| +1 | K083528 | Smith & Nephew Bipolar Adapter Cable, Model 72200022 | Smith & Nephew, Inc. | 2009 | — |
| +2 | K111262 | Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/… | Olsen Medical | 2012 | 2 |
| +3 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | Intuitive Surgical | 2024 | — |
| +3 | K143662 | Bissinger Monopolar Forceps and Cables | Medagent, Inc. | 2015 | — |
| +3 | K133167 | Monopolar Cautery Cord, Bipolar Cautery Cord | Intuitive Surgical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K043442 | Stryker RF Coaxial Bipolar Electrodes & CannulaeSummary page 1…mmon Name: Electrosurgical Connecting Cable Classification Name: Probe, Radiofrequency Lesion (GXI) Equivalent to: K043442 Stryker RF Coaxial Bipolar Electrodes and Cannulae K020354 Baylis Pain Management Generator… | 2005 |
| * | K020354 | Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International)Summary page 1…Probe, Radiofrequency Lesion (GXI) Equivalent to: K043442 Stryker RF Coaxial Bipolar Electrodes and Cannulae K020354 Baylis Pain Management Generator K053082 Baylis Pain Management Cooled Probe… | 2002 |
| * | K053082 | Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Summary page 1…K043442 Stryker RF Coaxial Bipolar Electrodes and Cannulae K020354 Baylis Pain Management Generator K053082 Baylis Pain Management Cooled Probe K031951 Baylis Transdiscal System… | 2005 |
| * | K031951 | Transdiscal System (Transdiscal Probe), Model TDP-17-150-6Summary page 1…K020354 Baylis Pain Management Generator K053082 Baylis Pain Management Cooled Probe K031951 Baylis Transdiscal System K052878 NeuroTherm NT 1000 RF Lesioning System Device Description:… | 2003 |
| * | K052878 | NT-1000Summary page 1…K053082 Baylis Pain Management Cooled Probe K031951 Baylis Transdiscal System K052878 NeuroTherm NT 1000 RF Lesioning System Device Description: The Stryker RF Parallel BiPolar Adaptor Cable will be u… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083528 | Smith & Nephew Bipolar Adapter Cable, Model 72200022 | 2009 | 4 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K083528 (Smith & Nephew, Inc., 2009) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K043442.
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 RF Parallel Bipolar Adaptor Cable is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications in combination with the separately cleared Stryker RF Generator, Electrodes and Cannulae.
Examples of procedures include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, and Rhizotomy
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/K061660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061660: Stryker RF Parallel Bipolar Adaptor Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061660
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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