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FDA 510(k)

PGLA90 聚(甘醇酸-共-L-乳酸)外科縫線（卡利普索）；PGLA90 聚(甘醇酸-共-L-乳酸)外科縫線（奧德賽斯）

K 號：K252820 · 2025-10-03

申請人Internacional Farmacéutica S.A DE C.V
決定日期2025-10-03
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

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) is the device name listed in this FDA 510(k) record. The listed applicant is Internacional Farmacéutica S.A DE C.V. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K252820. 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 PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)?

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Internacional Farmacéutica S.A DE C.V. The 510(k) number is K252820.

When did PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) receive FDA 510(k) clearance?

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K252820.

Who is the listed applicant for PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)?

The FDA 510(k) record lists Internacional Farmacéutica S.A DE C.V as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)?

The FDA product code for PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) is GAM.

相關臨床試驗

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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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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