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FDA 510(k)

1) PINION™ PDO无结缝合线 - 可吸收聚（P-二氧杂环己酮）无结缝合线；2) PINION™ PGA-PCL无结缝合线 - 可吸收聚甘氨酸酸 - 聚（甘醇酸-共己内酯）无结缝合线

K号: K232246 · 2024-04-25

申请人M/s. Meril Endo Surgery Private Limited.
决定日期2024-04-25
产品代码NEW
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

1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture is the device name listed in this FDA 510(k) record. The listed applicant is M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K232246. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture?

1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K232246.

When did 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture receive FDA 510(k) clearance?

1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture received FDA 510(k) clearance on 2024-04-25, under 510(k) number K232246.

Who is the listed applicant for 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture?

The FDA 510(k) record lists M/s. Meril Endo Surgery Private Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture?

The FDA product code for 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture is NEW.

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

列明M/s. Meril Endo Surgery Private Limited.为申报人的其他记录

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。

K252644PINION® PDO 无结缝合线 - 可吸收聚（P-二氧杂环己酮）无结缝合线；PINION® PGA-PCL 无结缝合线 - 可吸收聚（甘醇酸-共己内酯）无结缝合线K233386Monik® - 一次性内窥镜套管K230981Meriglu局部皮肤粘合剂K200452Meril-BonewaxK200320Mirus 圆形吻合器，Mirus 直线切割器和重装，Mirus 痔疮圆形吻合器，Mirus 直线吻合器和重装K200166Mirus 结扎夹，Mirus 结扎夹施用器

查看所有 11 个设备 →

相关器械（代码：NEW）

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。

K254238MINT MONO 缝线Hans Biomed CorporationK253879单固定PDOSamyang Holdings CorporationK261988Monodek® (POLYDIOXANONE) 染成紫罗兰色的单丝合成可吸收外科缝合线Teleflex Medical, LLCK252171倒刺 PDO 缝线Sutura Medical Technology, Inc.K252047STRATAFIX® 对称 PDS® Plus 无结组织控制装置ETHICON, Inc.K243897PDS™ Plus 抗菌 (聚二氧杂环己酮) 灭菌合成可吸收外科缝合线ETHICON, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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