510(k) · Cleared
ClearedCoreCath 2.7S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Advanced Energy · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 20, 2017 as substantially equivalent to K120909 (Medtronic Advanced Energy, LLC, 2012) after a 48-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Mar 20, 2017
- Review
- 48 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955247 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK955247 Olympus KD Series SphincterotomeOlympus America, Inc. · 1996
- 2 generations backK971328 Olympus CD-6C-1 Coagulation ElectrodeOlympus America, Inc. · 1997
- 1 generation backK120909 EC 2.7 Endoscopic CutterMedtronic Advanced Energy, LLC · 2012
- This deviceK170296 CoreCath 2.7SMedtronic Advanced Energy · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955247 | Olympus KD Series Sphincterotome | Olympus America, Inc. | 1996 | — |
| −2 | K971328 | Olympus CD-6C-1 Coagulation Electrode | Olympus America, Inc. | 1997 | — |
| −1 | K120909 | EC 2.7 Endoscopic Cutter | Medtronic Advanced Energy, LLC | 2012 | — |
| 0 (this device) | K170296 | CoreCath 2.7S | Medtronic Advanced Energy | 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 |
|---|---|---|---|
| * | K120909 | EC 2.7 Endoscopic CutterSummary page 4…vice and accessories (21 CFR 878.4400) Product Code: GEI Predicate Device: EC 2.7 Endoscopic Cutter (K120909) Device Description: The CoreCath 2.7S is a disposable, single-use monopolar RF (radio-… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K120909.
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 CoreCath 2.7S is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, providing electrosurgical hemostasis, and evacuation of surgical smoke during such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170296: CoreCath 2.7S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170296
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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