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FDA 510(k)

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)

K 號：K162388 · 2017-02-03

申請人Curaseal, Inc.
決定日期2017-02-03
產品代碼FTM
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

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) is the device name listed in this FDA 510(k) record. The listed applicant is Curaseal, Inc.. It received FDA 510(k) clearance on 2017-02-03 under 510(k) number K162388. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)?

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) is a medical device that received FDA 510(k) clearance on 2017-02-03. The listed applicant is Curaseal, Inc.. The 510(k) number is K162388.

When did CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) receive FDA 510(k) clearance?

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) received FDA 510(k) clearance on 2017-02-03, under 510(k) number K162388.

Who is the listed applicant for CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)?

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

What is the FDA product code for CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)?

The FDA product code for CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) is FTM.

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