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FDA 510(k)

PGLA90 聚(己内酯-co-L-乳酸)外科缝合线（Calypso）；PGLA90 聚(己内酯-co-L-乳酸)外科缝合线（Odysseus）

K号: K252820 · 2025-10-03

申请人Internacional Farmacéutica S.A DE C.V
决定日期2025-10-03
产品代码GAM
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：GAM）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253394涂层 VICRYL™ (Polyglactin 910) Plus 抗菌缝合线ETHICON, Inc.K253530Trexon™ 单丝合成可吸收缝合线MedtronicK253852MONOCRYL™ Plus 抗菌多甘露聚糖 – 25（单丝），无菌合成可吸收缝合线ETHICON, Inc.K252743STRATAFIX® 螺旋 PDS® Plus 无结组织控制装置；STRATAFIX® 螺旋 MONOCRYL® Plus 无结组织控制装置ETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K233265Monotime 和 Optime RPeters Surgical

官方来源

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