FDA 510(k)

不吸收性外科尼龍縫線

K 號：K212603 · 2021-12-22

申請人Shandong Haidike Medical Product Co., Ltd.

決定日期2021-12-22

產品代碼GAR

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

Non Absorbable Surgical Nylon Suture is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Haidike Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K212603. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Non Absorbable Surgical Nylon Suture?

Non Absorbable Surgical Nylon Suture is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Shandong Haidike Medical Product Co., Ltd.. The 510(k) number is K212603.

When did Non Absorbable Surgical Nylon Suture receive FDA 510(k) clearance?

Non Absorbable Surgical Nylon Suture received FDA 510(k) clearance on 2021-12-22, under 510(k) number K212603.

Who is the listed applicant for Non Absorbable Surgical Nylon Suture?

The FDA 510(k) record lists Shandong Haidike Medical Product Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non Absorbable Surgical Nylon Suture?

The FDA product code for Non Absorbable Surgical Nylon Suture is GAR.

其他以 Shandong Haidike Medical Product Co., Ltd. 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。

K232355不可吸收外科絲綫縫針

相關器械（代碼：GAR）

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。

K261484組織接合系統Tas Medical, Inc.K220980組織接合系統（TAS）Tas Medical, Inc.K212888高尼特尼龍單絲縫線Antarma, LLC Dba Golnit Sutures K192420Crownjun 尼龍縫線Kono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.K151165Aesculap Dafilon 不吸收性聚酰胺外科縫線Aesculap, 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。