TELLTALE Electrosurgical Guidewire System
FDA 510(k) clearance K252592 · decided 2025-11-13
Clearance details
- K-number
- K252592
- Device name
- TELLTALE Electrosurgical Guidewire System
- Applicant
- Telltale, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-08-15
- Decision date
- 2025-11-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- SGO
- Device class
- 2
- Regulation number
- 870.1254
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.