FDA 510(k)

彼得斯外科優先時吸收縫線（優先時）

K 號：K232372 · 2024-07-12

決定日期2024-07-12

產品代碼GAM

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

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) is the device name listed in this FDA 510(k) record. The listed applicant is Peters Surgical. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K232372. 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 Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)?

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Peters Surgical. The 510(k) number is K232372.

When did Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) receive FDA 510(k) clearance?

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) received FDA 510(k) clearance on 2024-07-12, under 510(k) number K232372.

Who is the listed applicant for Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)?

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

What is the FDA product code for Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)?

The FDA product code for Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) is GAM.

其他以 Peters Surgical 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。

K233265Monotime及Optime R

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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