510(k) · Cleared
Recalled · Class II · 2018Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olsen Medical · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 23, 2012 as substantially equivalent to K941908 (Quantum Instruments Corp., 1994) and 3 other predicates after a 384-day review. Its family tree reaches back 5 generations to 1999. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 23, 2012
- Review
- 384 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 5 generations to K991218 (1999). 18 ancestors in all, the oldest K896450 (1991). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
- 4 generations backK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
- 3 generations backK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- 2 generations backK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
- 1 generation backK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009
- This deviceK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012
- Descendant · cites it directly · 0 of its ownK241621 Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024
- Descendant · cites it directly · 0 of its ownK143662 Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK133167 Monopolar Cautery Cord, Bipolar Cautery CordIntuitive Surgical, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K241621Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024 · cites it directly0descendants
- K143662Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015 · cites it directly0descendants
- K133167Monopolar Cautery Cord, Bipolar Cautery CordIntuitive Surgical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991218 | Oratec Bipolar Ablation Probes | Oratec Interventions, Inc. | 1999 | — |
| −4 | K031371 | Saphyre Bipolar Ablation Probes | Smith & Nephew, Inc. | 2003 | — |
| −3 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| −2 | K061660 | Stryker RF Parallel Bipolar Adaptor Cable | Stryker Instruments | 2006 | — |
| −1 | K083528 | Smith & Nephew Bipolar Adapter Cable, Model 72200022 | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K111262 | Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/… | Olsen Medical | 2012 | — |
| +1 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | Intuitive Surgical | 2024 | — |
| +1 | K143662 | Bissinger Monopolar Forceps and Cables | Medagent, Inc. | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941908 | Quantum Mono-Polar Electrosurgical CableSummary page 2…KUi 2 PAgrc 2- IF -2 Instruments (K941 908, K9421 94), Sutter Medizintechnik (K073450), Smith and Nephew (K083528) and Richard Wolf Medical Instruments (K982667)… | 1994 |
| * | K942194 | Quantum BI-Polar Electrosurgical CableSummary page 2…KUi 2 PAgrc 2- IF -2 Instruments (K941 908, K9421 94), Sutter Medizintechnik (K073450), Smith and Nephew (K083528) and Richard Wolf Medical Instruments (K982667) based… | 1994 |
| * | K073450 | Sutter Electrosurgical CablesSummary page 2…KUi 2 PAgrc 2- IF -2 Instruments (K941 908, K9421 94), Sutter Medizintechnik (K073450), Smith and Nephew (K083528) and Richard Wolf Medical Instruments (K982667) based on the device's similarity to the… | 2008 |
| * | K083528 | Smith & Nephew Bipolar Adapter Cable, Model 72200022Summary page 2…PAgrc 2- IF -2 Instruments (K941 908, K9421 94), Sutter Medizintechnik (K073450), Smith and Nephew (K083528) and Richard Wolf Medical Instruments (K982667) based on the device's similarity to the predicated, device in intended use… | 2009 |
| Kept off the family tree | K982667 | FDA’s K982667 is Micromedics Nasal Septal Button Our reading of the summary gave K982667, FDA’s number for Micromedics Nasal Septal Button (Micromedics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Richard Wolf Medical Instruments”. Kept off the family tree. Summary page 2…PAgrc 2- IF -2 Instruments (K941 908, K9421 94), Sutter Medizintechnik (K073450), Smith and Nephew (K083528) and Richard Wolf Medical Instruments (K982667) based on the device's similarity to the predicated, device in intended use, materials, design, and technological c… | 1998 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2018 | Class II | Z-1942-2018 | Package design/selection | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
| May 11, 2018 | Class II | Z-1943-2018 | Package design/selection | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K241621 (Intuitive Surgical, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Olsen Medical Electrosurgical Cables/Adapters 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/K111262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111262: Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111262
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