510(k) · Cleared
Recalled · Class II · 2018Epix Electrosurgical Probe with Smoke Evacuation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 7, 2017 as substantially equivalent to K132300 (Applied Medical Resources Corp., 2014) after a 61-day review. Its family tree reaches back 2 generations to 1998. It has been recalled once.
- Decided
- Aug 7, 2017
- Review
- 61 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983623 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK983623 ModulapAtc Technologies, Inc. · 1998
- 1 generation backK132300 Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe…Applied Medical Resources Corp. · 2014
- This deviceK171684 Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983623 | Modulap | Atc Technologies, Inc. | 1998 | — |
| −1 | K132300 | Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe L-Hook Tip… | Applied Medical Resources Corp. | 2014 | — |
| 0 (this device) | K171684 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources Corporation | 2017 | — |
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 |
|---|---|---|---|
| * | K132300 | Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe L-Hook Tip, Epix…Summary page 4…Device Class: Class II Product Code: GEI Predicate Device: Epix® Electrosurgical Probes 510(k)#: K132300 Product Code: GEI Device Description: The Epix Electrosurgical Probe with Smoke Evacuation is a st… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2018 | Class II | Z-0509-2020 | Device Design | Unintentional shifting of the tip insulation of the firm's electrosurgical probes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171684: Epix Electrosurgical Probe with Smoke Evacuation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171684
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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