FDA 510(k)

HS縫合膠帶

K 號：K153307 · 2016-02-12

決定日期2016-02-12

產品代碼GAT

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

HS SutureTape is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153307. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HS SutureTape?

HS SutureTape is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Riverpoint Medical. The 510(k) number is K153307.

When did HS SutureTape receive FDA 510(k) clearance?

HS SutureTape received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153307.

Who is the listed applicant for HS SutureTape?

FDA 510(k) 記錄將 Riverpoint Medical 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for HS SutureTape?

The FDA product code for HS SutureTape is GAT.

其他以 Riverpoint 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。

K262677Iconix Knotless T K253024ProZip 齊結式植入體 K252201HS纖維 K252144Iconix Speed Anchor；Iconix Speed HA+ Anchor K243323Iconix無縫錨 K243203OC 無節結環環柔軟锚；OC 無節環柔軟锚

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相關器械（代碼：GAT）

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。

K253910釘線 - 緝合針線及膠帶GM Dos Reis Industria e Comercio Ltda.K261021EasyWhip 家族Winter Innovations, Inc.K260775聚乙烯；聚乙烯融合；聚乙烯正骨膠帶™Teleflex Medical, LLC K254275超縫全綠延伸線Threadstone, LLC K254188半月板VersaflexGM Dos Reis Industria e Comercio Ltda.K253145預縫合腱Rti Surgical, Inc.

官方來源

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