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FDA 510(k)

TELLTALE Electrosurgical Guidewire System

K-Number: K252592 · 2025-11-13

ApplicantTelltale, LLC
Decision Date2025-11-13
Product CodeSGO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELLTALE Electrosurgical Guidewire System is the device name listed in this FDA 510(k) record. The listed applicant is Telltale, LLC. It received FDA 510(k) clearance on 2025-11-13 under 510(k) 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. The listed applicant is Telltale, LLC. The 510(k) number is K252592.

When did TELLTALE Electrosurgical Guidewire System receive FDA 510(k) clearance?

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

Who is the listed applicant for TELLTALE Electrosurgical Guidewire System?

The FDA 510(k) record lists Telltale, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

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.

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