FDA 510(k)

BioWave BioWraps

K号: K261522 · 2026-06-03

决定日期2026-06-03

产品代码GXY

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决定实质等同

器械摘要

BioWave BioWraps is the device name listed in this FDA 510(k) record. The listed applicant is Biowave Corporation. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K261522. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioWave BioWraps?

BioWave BioWraps is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Biowave Corporation. The 510(k) number is K261522.

When did BioWave BioWraps receive FDA 510(k) clearance?

BioWave BioWraps received FDA 510(k) clearance on 2026-06-03, under 510(k) number K261522.

Who is the listed applicant for BioWave BioWraps?

The FDA 510(k) record lists Biowave Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioWave BioWraps?

The FDA product code for BioWave BioWraps is GXY.

列明Biowave Corporation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。

K203158BioWave BioWraps K210202BioWaveGO RX K180943BioWaveGO

相关器械（代码：GXY）

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。

K262654Dexus假肢系统（MSL2，MSR2）Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM 杯 MRI/CT（型号 72704/21US，72704/23US，72704/25US，72704/27US）Ambu® NeurolineTM 杯 MRI/CT套装（型号 72704/21-1010US，72704/21-1010US，72704/23-1010US，72704/25-1010US，72704/27-1010US）Ambu® NeurolineTM 杯 MRI/CT迷你套装（型号 72704/21-0301US，72704/23-0301US，72704/25-0301US，72704/27-0301US）Ambu A/S K261442Charlotte ACC25 表面电极阵列；Charlotte ACC25 可重复使用表面电极阵列Cadwell Industries, Inc.K253237Elde 医疗电极（T5/ 5cm x 5cm 电极 T10/ 5cm x 10cm 电极）Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR 条件杯电极Technomed Europe K252439Tutamen自粘电极Dongguan Tutamen Metalwork Co., Ltd.

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