MONOFIX PGCL，無結節傷口縫合設備
K 號：K212810 · 2022-08-05
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器材摘要
MONOFIX PGCL, knotless wound closure device is the device name listed in this FDA 510(k) record. The listed applicant is Samyang Holdings Corp., Ltd.. It received FDA 510(k) clearance on 2022-08-05 under 510(k) number K212810. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MONOFIX PGCL, knotless wound closure device?
MONOFIX PGCL, knotless wound closure device is a medical device that received FDA 510(k) clearance on 2022-08-05. The listed applicant is Samyang Holdings Corp., Ltd.. The 510(k) number is K212810.
When did MONOFIX PGCL, knotless wound closure device receive FDA 510(k) clearance?
MONOFIX PGCL, knotless wound closure device received FDA 510(k) clearance on 2022-08-05, under 510(k) number K212810.
Who is the listed applicant for MONOFIX PGCL, knotless wound closure device?
The FDA 510(k) record lists Samyang Holdings Corp., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MONOFIX PGCL, knotless wound closure device?
The FDA product code for MONOFIX PGCL, knotless wound closure device is GAM.
相關臨床試驗
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相關器械（代碼：GAM）
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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