FDA 510(k)

Nisus NPWT 內容器 500-mL (CPC-500)

K 號：K261291 · 2026-05-21

決定日期2026-05-21

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

Nisus NPWT Canister 500-mL (CPC-500) is the device name listed in this FDA 510(k) record. The listed applicant is Cork Medical. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K261291. 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 Nisus NPWT Canister 500-mL (CPC-500)?

Nisus NPWT Canister 500-mL (CPC-500) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Cork Medical. The 510(k) number is K261291.

When did Nisus NPWT Canister 500-mL (CPC-500) receive FDA 510(k) clearance?

Nisus NPWT Canister 500-mL (CPC-500) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K261291.

Who is the listed applicant for Nisus NPWT Canister 500-mL (CPC-500)?

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

What is the FDA product code for Nisus NPWT Canister 500-mL (CPC-500)?

The FDA product code for Nisus NPWT Canister 500-mL (CPC-500) is OMP.

其他以 Cork Medical 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。

K243187Nisus ONE 負壓治療系統 (OCMPP-100)K241061VERSA 負壓治療系統 (VCMPP-100)K230677Cork醫療VERSA負壓創傷系統（VCMPP-100）

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。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 負壓傷口治療系統Convatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K254019傷口基因NPWT系統Bechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

官方來源

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