FDA 510(k)

RENASYS EDGE (66803126)

K 號：K260646 · 2026-05-27

決定日期2026-05-27

產品代碼OMP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

RENASYS EDGE (66803126) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260646. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RENASYS EDGE (66803126)?

RENASYS EDGE (66803126) is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K260646.

When did RENASYS EDGE (66803126) receive FDA 510(k) clearance?

RENASYS EDGE (66803126) received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260646.

Who is the listed applicant for RENASYS EDGE (66803126)?

FDA 510(k) 記錄將史密斯與內夫公司（Smith & Nephew Medical, Ltd.）列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for RENASYS EDGE (66803126)?

The FDA product code for RENASYS EDGE (66803126) is OMP.

其他以 Smith & Nephew Medical, Ltd. 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：OMP）

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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官方來源

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