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FDA 510(k)

esolution® 食道拉開器

K 號:K243233 · 2024-11-09

決定日期2024-11-09
產品代碼QXU
諮詢委員會履歷
決定相當於

器材摘要

esolution® Esophageal Retractor is the device name listed in this FDA 510(k) record. The listed applicant is S4 Medical Corp.. It received FDA 510(k) clearance on 2024-11-09 under 510(k) number K243233. The device is classified under product code QXU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the esolution® Esophageal Retractor?

esolution® Esophageal Retractor is a medical device that received FDA 510(k) clearance on 2024-11-09. The listed applicant is S4 Medical Corp.. The 510(k) number is K243233.

When did esolution® Esophageal Retractor receive FDA 510(k) clearance?

esolution® Esophageal Retractor received FDA 510(k) clearance on 2024-11-09, under 510(k) number K243233.

Who is the listed applicant for esolution® Esophageal Retractor?

The FDA 510(k) record lists S4 Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for esolution® Esophageal Retractor?

The FDA product code for esolution® Esophageal Retractor is QXU.

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