510(k) · Cleared
ClearedEpix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe L-Hook Tip, Epix Electrosurgical Probe J-Hook Tip, RE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 24, 2014 as substantially equivalent to K983623 (Atc Technologies, Inc., 1998) after a 184-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jan 24, 2014
- Review
- 184 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983623 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK983623 ModulapAtc Technologies, Inc. · 1998
- This deviceK132300 Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe…Applied Medical Resources Corp. · 2014
- Descendant · cites it directly · 0 of its ownK171684 Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources Corporation · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171684Epix Electrosurgical Probe with Smoke EvacuationApplied Medical Resources Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983623 | Modulap | Atc Technologies, Inc. | 1998 | — |
| 0 (this device) | K132300 | Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe L-Hook Tip… | Applied Medical Resources Corp. | 2014 | — |
| +1 | K171684 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources Corporation | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K983623 | ModulapSummary page 1…oduct Code: GEl Regulation: 21 CER 878.4400 Predicate Device: ModulapTM Reusable Unipolar Electrosurgical Probes 510(k)#: K983623 Product Code: GCJ Device Description: Electrosurgical probes are reusable suction and irrigati… | 1998 |
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 |
|---|---|---|---|
| K171684 | Epix Electrosurgical Probe with Smoke Evacuation | 2017 | 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?
- Its one ancestor has no recall.
- Of its descendants, K171684 (Applied Medical Resources Corporation, 2017) 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. 2014, 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 Epixo Electrosurgical Probes are indicated for irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132300: Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe L-Hook Tip, Epix Electrosurgical Probe J-Hook Tip, RE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132300
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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