FDA 510(k)

尿路C型膀胱镜

K号: K202921 · 2021-05-04

决定日期2021-05-04

产品代码FAJ

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决定实质等同

器械摘要

Uro-G Cystoscope is the device name listed in this FDA 510(k) record. The listed applicant is Uroviu Corporation. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K202921. 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 Uro-G Cystoscope?

Uro-G Cystoscope is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Uroviu Corporation. The 510(k) number is K202921.

When did Uro-G Cystoscope receive FDA 510(k) clearance?

Uro-G Cystoscope received FDA 510(k) clearance on 2021-05-04, under 510(k) number K202921.

Who is the listed applicant for Uro-G Cystoscope?

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

What is the FDA product code for Uro-G Cystoscope?

The FDA product code for Uro-G Cystoscope is FAJ.

列明Uroviu 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。

K253226UV5000W 处理器 K250797UV5000 处理器 K243196Uro-G HD 膀胱镜（1520）K232837Uro-G HD 弹性膀胱镜 K182876尿路N型膀胱镜 K171500尿路膀胱镜

查看所有 7 个设备 →

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 K253696CFlex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）Verathon Medical (Canada) Ulc 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

官方来源

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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。