510(k) · Cleared
ClearedElectrosurgical Cautery Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microline Pentax, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 20, 1998 as substantially equivalent to K913108 (Olsen Electrosurgical, Inc., 1991) after a 48-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- May 20, 1998
- Review
- 48 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913108 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK913108 Teflon Coated Electrodes/Electrodes HandlesOlsen Electrosurgical, Inc. · 1991
- This deviceK981188 Electrosurgical Cautery ProbesMicroline Pentax, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK151480 Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources · 2016
Most influential descendants
Showing 1 of 1 · See all- K151480Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913108 | Teflon Coated Electrodes/Electrodes Handles | Olsen Electrosurgical, Inc. | 1991 | — |
| 0 (this device) | K981188 | Electrosurgical Cautery Probes | Microline Pentax, Inc. | 1998 | — |
| +1 | K151480 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K913108 | Teflon Coated Electrodes/Electrodes HandlesSummary page 1…ined C. Identification of Predicate Device(s) The Microline Electrosurgical Cautery Probes are substantially equivalent to those offered by Olsen Electrosurgical Inc. (K913108) previously cleared and currently marketed. D. Device Description The Microline Electrosurgical Cautery Probes are a line of no… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151480 | Epix Electrosurgical Probe with Smoke Evacuation | 2016 | 0 |
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 Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
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/K981188 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981188: Electrosurgical Cautery Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981188
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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