FDA 510(k)

SRGC-06

K 號：K261246 · 2026-06-18

決定日期2026-06-18

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

SRGC-06 is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K261246. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SRGC-06?

SRGC-06 is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is GC America, Inc.. The 510(k) number is K261246.

When did SRGC-06 receive FDA 510(k) clearance?

SRGC-06 received FDA 510(k) clearance on 2026-06-18, under 510(k) number K261246.

Who is the listed applicant for SRGC-06?

FDA 510(k) 記錄將 GC America, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SRGC-06?

The FDA product code for SRGC-06 is EBF.

其他以 GC America, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：EBF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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