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FDA 510(k)

TELLTALE 電外科導絲系統

K 號:K252592 · 2025-11-13

申請人Telltale, LLC
決定日期2025-11-13
產品代碼SGO
諮詢委員會履歷
決定相當於

器材摘要

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.

常見問題

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.

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