TELLTALE Electrosurgical Guidewire System— 510(k) K252592

Name: FDA 510(k) clearance K252592
Creator: U.S. Food and Drug Administration
Published: 2025-11-13

Substantially Equivalent

Telltale, LLC

FDA 510(k) clearance K252592 for TELLTALE Electrosurgical Guidewire System, Substantially Equivalent on 2025-11-13. Applicant: Telltale, LLC. Device class: 2.

Clearance details

Applicant: Telltale, LLC
Product code: Code SGO
Device class: Class 2
Regulation: 21 CFR 870.1254
Advisory panel: Cardiovascular
Date received: 2025-08-15
Decision date: 2025-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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