免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Nisus ONE 負壓治療系統 (OCMPP-100)

K 號：K243187 · 2025-06-27

申請人Cork Medical
決定日期2025-06-27
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

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) is the device name listed in this FDA 510(k) record. The listed applicant is Cork Medical. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243187. 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 ONE Negative Pressure Wound Therapy System (OCMPP-100)?

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Cork Medical. The 510(k) number is K243187.

When did Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) receive FDA 510(k) clearance?

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243187.

Who is the listed applicant for Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)?

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 ONE Negative Pressure Wound Therapy System (OCMPP-100)?

The FDA product code for Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) is OMP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K261291Nisus NPWT 內容器 500-mL (CPC-500)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 BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 內容器 500-mL (CPC-500)Cork MedicalK254019傷口基因NPWT系統Bechtel Medical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑