FDA 510(k)

Ran-Flex-B 骨髓穿刺针

K号: K202287 · 2020-09-18

决定日期2020-09-18

产品代码KNW

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决定实质等同

器械摘要

Ran-Flex-B Bone Marrow Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ranfac Corporation. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K202287. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ran-Flex-B Bone Marrow Aspiration Needle?

Ran-Flex-B Bone Marrow Aspiration Needle is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Ranfac Corporation. The 510(k) number is K202287.

When did Ran-Flex-B Bone Marrow Aspiration Needle receive FDA 510(k) clearance?

Ran-Flex-B Bone Marrow Aspiration Needle received FDA 510(k) clearance on 2020-09-18, under 510(k) number K202287.

Who is the listed applicant for Ran-Flex-B Bone Marrow Aspiration Needle?

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

What is the FDA product code for Ran-Flex-B Bone Marrow Aspiration Needle?

The FDA product code for Ran-Flex-B Bone Marrow Aspiration Needle is KNW.

列明Ranfac 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。

K223612Ranfac 侧入路骨髓抽吸针 (CRVS-BMA-LA)K190177J-Type骨髓活检针，T-Type骨髓活检针，镊子型骨髓活检针 K183146Ranfac 软骨活检针

相关器械（代码：KNW）

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。

K260517自动核心活检仪器Zhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™乳腺活检和组织移除系统Bard Peripheral Vascular, Inc.K262792Brevera活检系统，配备CorLumina成像技术（BREVDISP09）Hologic, Inc.K260572骨髓马克思曼Medimetrix, LLC K261196Promisemed VeriEcto 自动活检针Promisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR 双真空辅助乳腺活检系统控制模块；Mammotome Prima™ MR 双真空辅助乳腺活检系统一次性探头，8号；Mammotome Prima™ MR 双真空辅助乳腺活检系统一次性靶向套件，8号；Mammotome Prima™ MR 双真空辅助乳腺活检系统脚踏开关；Mammotome Prima™ MR 双真空辅助乳腺活检系统可重复使用的托盘；Mammotome Prima™ MR 双真空辅助乳腺活检系统电池充电器Devicor Medical Products, Inc.

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