FDA 510(k)

LUMINELLE DTx 系统

K号: K210512 · 2021-06-30

决定日期2021-06-30

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

LUMINELLE DTx System is the device name listed in this FDA 510(k) record. The listed applicant is Uvision360, Inc.. It received FDA 510(k) clearance on 2021-06-30 under 510(k) number K210512. 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 LUMINELLE DTx System?

LUMINELLE DTx System is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is Uvision360, Inc.. The 510(k) number is K210512.

When did LUMINELLE DTx System receive FDA 510(k) clearance?

LUMINELLE DTx System received FDA 510(k) clearance on 2021-06-30, under 510(k) number K210512.

Who is the listed applicant for LUMINELLE DTx System?

The FDA 510(k) record lists Uvision360, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMINELLE DTx System?

The FDA product code for LUMINELLE DTx System is FAJ.

列明Uvision360, Inc.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。

K192278Luminelle DTx 宫腔镜系统，Luminelle Dx 360 可旋转一次性套管（诊断）K190827Luminelle DTx 宫腔镜系统，Luminelle 360 可旋转无菌一次性套管硬管 K181909Luminelle DTx 宫腔镜系统

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 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

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。