FDA product code SGO: Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
SGO is the FDA product code for percutaneous catheter for electrosurgical cutting heart valve leaflets concomitant to transcatheter valve procedures. It is a Class II device, regulated under 21 CFR 870.1254 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under SGO, 1 in the last five years. The average 510(k) review took 90 days (median 90); 90 days on average over the last three years.
Definition
The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure
Classification
| Field | Value |
|---|---|
| Device name | Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures |
| Device class | Class II |
| Regulation | 21 CFR 870.1254 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for SGO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every SGO clearance
Top SGO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Telltale, LLC | 1 | 2025-11-13 |
Most recent SGO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252592 | Telltale, LLC | TELLTALE Electrosurgical Guidewire System | 2025-11-13 | 90 |
Recalls for SGO devices
openFDA lists no recalls for product code SGO.
Frequently asked questions
What is FDA product code SGO?
SGO is the FDA product code for percutaneous catheter for electrosurgical cutting heart valve leaflets concomitant to transcatheter valve procedures. It is a Class II device, regulated under 21 CFR 870.1254 and reviewed by the Cardiovascular panel.
What device class is SGO?
Class II, regulation 21 CFR 870.1254. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGO?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most SGO clearances?
Telltale, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SGO
- Run a recall and safety report across every SGO manufacturer
- Watch product code SGO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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