FDA 510(k)

CFlex膀胱镜 - 标准偏转（0570-0455）；CFlex膀胱镜 - 反向偏转（0570-0456）；CystoView监视器（0570-0465）

K号: K253696 · 2026-05-11

决定日期2026-05-11

产品代码FAJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) is the device name listed in this FDA 510(k) record. The listed applicant is Verathon Medical (Canada) Ulc. It received FDA 510(k) clearance on 2026-05-11 under 510(k) number K253696. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)?

CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Verathon Medical (Canada) Ulc. The 510(k) number is K253696.

When did CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) receive FDA 510(k) clearance?

CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) received FDA 510(k) clearance on 2026-05-11, under 510(k) number K253696.

Who is the listed applicant for CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)?

The FDA 510(k) record lists Verathon Medical (Canada) Ulc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)?

The FDA product code for CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) is FAJ.

列明Verathon Medical (Canada) Ulc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。

K230948BFlex™ 2 Slim 3.8 Single-Use Bronchoscope K211947GlideScope BFlex 2.8 单次使用支气管镜 K193488GlideScope BFlex 3.8 单次使用支气管镜 K191948GlideScope BFlex 5.8 单次使用支气管镜 K183256GlideScope BFlex 单次使用支气管镜系统

相关器械（代码：FAJ）

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。

K260649OES ELITE 球囊内镜及其附件；球囊，17 Fr. (WA2C17BO)；球囊，19.8 Fr. (WA2C19BO)；球囊，21 Fr. (WA2C21BO)；球囊，21 Fr.，用于带斜坡的套管 (WA2C21RO)；球囊，21 Fr.，长 (WA2C21LO)；球囊，21 Fr.，用于直型套管 (WA2C21SO)；球囊，22.5 Fr. (WA2C22BO)；球囊，25 Fr. (WA2C25BO)；光学球囊，19.8 Fr. (WA2C19BV)；光学球囊，21 Fr. (WA2C21BV)；光学球囊，21 Fr.，用于直型套管 (WA2C21SV)；光学球囊，Olympus Winter & Ibe GmbH K253892Strauss Surgical膀胱镜和宫腔镜（STS-2040-302ASA HD内窥镜，4 x 302 mm，视角. 直. 0°，标准型，可高压灭菌）；Strauss Surgical膀胱镜和宫腔镜（STS-2040-302AA HD内窥镜，4 x 302 mm，视角. 直. 0°，广角，可高压灭菌）；Strauss Surgical膀胱镜和宫腔镜（STS-2040-302BA HD内窥镜，4 x 302 mm，视角. 直. 30°，广角，可高压灭菌）；Strauss Surgical膀胱镜和宫腔镜（STS-2040-302BSA HD内窥镜，4 x 302 mm，视角. 直. 30°，Strauss Surgical USA K253905PrimeSight UltraView系统Cogentix Medical, Inc.K260271Strauss Surgical膀胱镜、宫腔镜和配件工具American Medical Endoscopy, Inc.K253226UV5000W 处理器Uroviu Corporation K251140Zenflow 春季范围Zenflow, Inc.

官方来源

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