FDA 510(k)

間斷導尿管（未定案）

K 號：K211436 · 2022-01-27

決定日期2022-01-27

產品代碼GBM

諮詢委員會GU

決定相當於

器材摘要

Intermittent Catheter (Not Finalized) is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K211436. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Intermittent Catheter (Not Finalized)?

Intermittent Catheter (Not Finalized) is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Hollister Incorporated. The 510(k) number is K211436.

When did Intermittent Catheter (Not Finalized) receive FDA 510(k) clearance?

Intermittent Catheter (Not Finalized) received FDA 510(k) clearance on 2022-01-27, under 510(k) number K211436.

Who is the listed applicant for Intermittent Catheter (Not Finalized)?

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

What is the FDA product code for Intermittent Catheter (Not Finalized)?

The FDA product code for Intermittent Catheter (Not Finalized) is GBM.

其他以 Hollister Incorporated 為申請人之記錄

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相關器械（代碼：GBM）

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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