FDA 510(k)

Meriglu局部皮肤粘合剂

K号: K230981 · 2024-03-16

申请人M/s. Meril Endo Surgery Private Limited.

决定日期2024-03-16

产品代码MPN

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决定实质等同

器械摘要

Meriglu Topical Skin Adhesive 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 2024-03-16 under 510(k) number K230981. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Meriglu Topical Skin Adhesive?

Meriglu Topical Skin Adhesive is a medical device that received FDA 510(k) clearance on 2024-03-16. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K230981.

When did Meriglu Topical Skin Adhesive receive FDA 510(k) clearance?

Meriglu Topical Skin Adhesive received FDA 510(k) clearance on 2024-03-16, under 510(k) number K230981.

Who is the listed applicant for Meriglu Topical Skin Adhesive?

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 Meriglu Topical Skin Adhesive?

The FDA product code for Meriglu Topical Skin Adhesive is MPN.

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。

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相关器械（代码：MPN）

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。

K243990BondEase 2 表面皮肤粘合剂Optmed, Inc.K250950CUTIVA™局部皮肤粘合剂（RM1700）；CUTIVA™ PLUS皮肤闭合系统（RM1739）Okapi Medical, LLC Dba Resivant Medical K234114CUTIVA™局部皮肤粘合剂（RM-1700）；CUTIVA™ PLUS皮肤闭合系统（RM-1739）Okapi Medical, LLC Dba Resivant Medical K233458CM005 标准 (CM005)；CM004 迷你 (CM004)Connexicon Medical , Ltd.K212246Exofin 精密笔Chemence Medical, Inc.K200264Exofin 高粘度局部皮肤粘合剂Chemence Medical, Inc.

官方来源

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