G4Derm / G4Derm Plus 合成伤口基质
K号: K222025 · 2023-10-11
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器械摘要
G4Derm / G4Derm Plus Synthetic Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Gel4med, Inc.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K222025. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the G4Derm / G4Derm Plus Synthetic Wound Matrix?
G4Derm / G4Derm Plus Synthetic Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Gel4med, Inc.. The 510(k) number is K222025.
When did G4Derm / G4Derm Plus Synthetic Wound Matrix receive FDA 510(k) clearance?
G4Derm / G4Derm Plus Synthetic Wound Matrix received FDA 510(k) clearance on 2023-10-11, under 510(k) number K222025.
Who is the listed applicant for G4Derm / G4Derm Plus Synthetic Wound Matrix?
The FDA 510(k) record lists Gel4med, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for G4Derm / G4Derm Plus Synthetic Wound Matrix?
The FDA product code for G4Derm / G4Derm Plus Synthetic Wound Matrix is FRO. This falls under the Anesthesiology category.
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。
相关器械（代码：FRO）
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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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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