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FDA 510(k)

Colonplus 肠道套件小號、Colonplus 肠道套件大號、Colonplus 肠道套件配止衝圈 6、Colonplus 肠道套件配止衝圈 10

K 號：K152834 · 2016-08-10

申請人Colonplus Equipments & Speculums, S.L.
決定日期2016-08-10
產品代碼KPL
諮詢委員會GU
決定相當於

器材摘要

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 is the device name listed in this FDA 510(k) record. The listed applicant is Colonplus Equipments & Speculums, S.L.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K152834. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10?

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Colonplus Equipments & Speculums, S.L.. The 510(k) number is K152834.

When did Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 receive FDA 510(k) clearance?

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 received FDA 510(k) clearance on 2016-08-10, under 510(k) number K152834.

Who is the listed applicant for Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10?

The FDA 510(k) record lists Colonplus Equipments & Speculums, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10?

The FDA product code for Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 is KPL.

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

相關器械（代碼：KPL）

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。

K201861生物柔絲系統Gnali Bocia S.R.L.K180800結腸加長型、小號及直型水套Colonic Plus

官方來源

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