gentleheel®成人切口设备
K号: K242664 · 2024-11-05
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器械摘要
gentleheel® Adult Incision Device is the device name listed in this FDA 510(k) record. The listed applicant is Gri-Alleset, Inc.. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K242664. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the gentleheel® Adult Incision Device?
gentleheel® Adult Incision Device is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Gri-Alleset, Inc.. The 510(k) number is K242664.
When did gentleheel® Adult Incision Device receive FDA 510(k) clearance?
gentleheel® Adult Incision Device received FDA 510(k) clearance on 2024-11-05, under 510(k) number K242664.
Who is the listed applicant for gentleheel® Adult Incision Device?
The FDA 510(k) record lists Gri-Alleset, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for gentleheel® Adult Incision Device?
The FDA product code for gentleheel® Adult Incision Device is FMK.
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。
列明Gri-Alleset, Inc.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。
相关器械（代码：FMK）
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。
K262526安全采血针（XL）Tianjin Huahong Technology Co., Ltd.K261045Verifine 安全采血针Promisemed Hangzhou Meditech Co., Ltd.K260191安全型刀片（XXXVII）Tianjin Huahong Technology Co., Ltd.K253605安全足跟注射针Ningbo Medsun Medical Co., Ltd.K252490足跟棒安全刀片（HHZ-II，HHZ-III，HHZ-IV）Tianjin Huahong Technology Co., Ltd.K251694安全注射针Tianjin Huahong Technology Co., Ltd.
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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