510(k) · Cleared
ClearedOratec Bipolar Ablation Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oratec Interventions, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 13, 1999 after a 154-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.
- Decided
- Sep 13, 1999
- Review
- 154 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 3 citing it directly.
- This deviceK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
- Descendant · cites it directly · 19 of its ownK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
- Descendant · 2 generations on · 17 of its ownK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- Descendant · 3 generations on · 7 of its ownK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
- Descendant · 3 generations on · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
- Descendant · 4 generations on · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K031371Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003 · cites it directly19descendants
- K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005 · 2 generations on17descendants
- K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016 · 3 generations on7descendants
- K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · 3 generations on5descendants
- K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991218 | Oratec Bipolar Ablation Probes | Oratec Interventions, Inc. | 1999 | — |
| +1 | K031371 | Saphyre Bipolar Ablation Probes | Smith & Nephew, Inc. | 2003 | — |
| +2 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| +3 | K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Relievant Medsystems | 2016 | — |
| +3 | K061660 | Stryker RF Parallel Bipolar Adaptor Cable | Stryker Instruments | 2006 | — |
| +4 | K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | ArthroCare Ablation Probes Named without a submission number |
What descends from it? (24)
See all 243 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031371 (Smith & Nephew, Inc., 2003) has gone furthest, with 19 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.
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 Bipolar Ablation Probes are disposable, bipolar electrosurgical devices intended
to be used for ablation and hemostasis of soft tissues in arthroscopic procedures.
They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.
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/K991218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991218: Oratec Bipolar Ablation Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991218
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