510(k) · Cleared
ClearedTELLTALE Electrosurgical Guidewire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telltale, LLC · SGO Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Cleared on Nov 13, 2025 as substantially equivalent to DEN240017 (Pi-Cardia, Ltd., 2024) after a 90-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Nov 13, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- SGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240017 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240017 ShortCutPi-Cardia, Ltd. · 2024
- This deviceK252592 TELLTALE Electrosurgical Guidewire SystemTelltale, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240017 | ShortCut | Pi-Cardia, Ltd. | 2024 | — |
| 0 (this device) | K252592 | TELLTALE Electrosurgical Guidewire System | Telltale, LLC | 2025 | — |
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 SGO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN240017 | ShortCutSummary page 5…Regulatory Class: Class II per 21 CFR 870.1254 Product Code: SGO Predicate Device Predicate Name and 510(k) Number: ShortCut, Pi-Cardia Ltd, DEN240017 This predicate has not been subject to a design-related recall. No reference predicates were used in this submission. Device Des… | 2024 |
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?
- Its one ancestor has no recall.
How does its category compare?
All SGO devicesSGO Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGO
Too few SGO 510(k)s in any year since 2007 to give a median.
Recalls per year · SGO
No recall names SGO since 2007.
Adverse event reports per year · SGO
No MAUDE report names SGO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TELLTALE Electrosurgical Guidewire System is indicated for transcatheter electrosurgical traversal and laceration of native and bioprosthetic tissue in patients at risk of coronary obstruction during TAVR.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252592: TELLTALE Electrosurgical Guidewire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252592
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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