FDA 510(k)

TELLTALE Electrosurgical Guidewire System

K-Number: K252592 · 2025-11-13

Decision Date2025-11-13

Product CodeSGO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TELLTALE Electrosurgical Guidewire System is a medical device manufactured by Telltale, LLC. It received FDA 510(k) clearance on 2025-11-13 under approval number K252592. The device is classified under product code SGO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELLTALE Electrosurgical Guidewire System?

TELLTALE Electrosurgical Guidewire System is a medical device that received FDA 510(k) clearance on 2025-11-13. It is manufactured by Telltale, LLC. The 510(k) number is K252592.

When was TELLTALE Electrosurgical Guidewire System approved by the FDA?

TELLTALE Electrosurgical Guidewire System received FDA 510(k) clearance on 2025-11-13, under approval number K252592.

What company makes TELLTALE Electrosurgical Guidewire System?

TELLTALE Electrosurgical Guidewire System is manufactured by Telltale, LLC.

What is the FDA product code for TELLTALE Electrosurgical Guidewire System?

The FDA product code for TELLTALE Electrosurgical Guidewire System is SGO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.