510(k) · Cleared
ClearedMonopolar Cautery Cord, Bipolar Cautery Cord
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 7, 2014 as substantially equivalent to K111262 (Olsen Medical, 2012) after an 82-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Jan 7, 2014
- Review
- 82 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K991218 (1999). 19 ancestors in all, the oldest K896450 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
- 5 generations backK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
- 4 generations backK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- 3 generations backK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
- 2 generations backK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009
- 1 generation backK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012 · Recalled
- This deviceK133167 Monopolar Cautery Cord, Bipolar Cautery CordIntuitive Surgical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991218 | Oratec Bipolar Ablation Probes | Oratec Interventions, Inc. | 1999 | — |
| −5 | K031371 | Saphyre Bipolar Ablation Probes | Smith & Nephew, Inc. | 2003 | — |
| −4 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| −3 | K061660 | Stryker RF Parallel Bipolar Adaptor Cable | Stryker Instruments | 2006 | — |
| −2 | K083528 | Smith & Nephew Bipolar Adapter Cable, Model 72200022 | Smith & Nephew, Inc. | 2009 | — |
| −1 | K111262 | Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/… | Olsen Medical | 2012 | 2 |
| 0 (this device) | 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 |
| 1994 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K111262 | Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…Summary page 2…ogical Characteristics: The Monopolar and Bipolar Cautery Cords are substantially equivalent to the predicate devices, Olsen Medical Electrosurgical Cables/Adapters (KI 111262) in terms of design, materials, technological characteristics, and intended use. Performance Data: Performance test data demonst… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 19 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111262.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Monapolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133167: Monopolar Cautery Cord, Bipolar Cautery Cord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133167
Report an extraction error
Are you the manufacturer?
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