510(k) · Cleared
ClearedModification to Tac-S Monopolar Cautery Probe Family
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 Dec 16, 1998 as substantially equivalent to K963157 (Oratec Interventions, Inc., 1996) after a 23-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Dec 16, 1998
- Review
- 23 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963157 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963157 Oratec Interventions Model Tac-S Monopolar Cautery Probe (Modify)Oratec Interventions, Inc. · 1996
- This deviceK984185 Modification to Tac-S Monopolar Cautery Probe FamilyOratec Interventions, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK991830 Capsular Shrinkage ElectrodeLinvatec Corp. · 1999 · Recalled
- Descendant · cites it directly · 0 of its ownK990859 Deflectable Tac Electrothermal ProbeOratec Interventions, Inc. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963157 | Oratec Interventions Model Tac-S Monopolar Cautery Probe (Modify) | Oratec Interventions, Inc. | 1996 | — |
| 0 (this device) | K984185 | Modification to Tac-S Monopolar Cautery Probe Family | Oratec Interventions, Inc. | 1998 | — |
| +1 | K991830 | Capsular Shrinkage Electrode | Linvatec Corp. | 1999 | 1 |
| +1 | K990859 | Deflectable Tac Electrothermal Probe | Oratec Interventions, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (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 |
|---|---|---|---|
| * | K963157 | Oratec Interventions Model Tac-S Monopolar Cautery Probe (Modify)Summary page 1…robe Family: TAC-S Monopolar Cautery Probe MiniTAC™-S Monopolar Cautery Probe v MicroTAC-S™ Monopolar Cautery Probe C. Predicate Device: TAC-S™ Monopolar Cautery Probe, K963157 D. Device Description: The ORATEC Interventions TAC-S, MiniTAC-S, and MicroTAC-S Monopolar Cautery Probes are single-use electr… | 1996 |
What descends from it? (2)
2 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?
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 TAC-S™ Monopolar Cautery Probes are disposable electrosurgical devices intended to be used in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are intended to be used with Oratec™ Interventions ElectroThermal™ Generators.
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/K984185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984185: Modification to Tac-S Monopolar Cautery Probe Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984185
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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