FDA 510(k)

BD Touchless™ Plus 男女通用预润滑尿道导管套装

K号: K254076 · 2026-05-29

决定日期2026-05-29

产品代码FCM

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决定Unknown

器械摘要

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K254076. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit?

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K254076.

When did BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit receive FDA 510(k) clearance?

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit received FDA 510(k) clearance on 2026-05-29, under 510(k) number K254076.

Who is the listed applicant for BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit?

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

What is the FDA product code for BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit?

The FDA product code for BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit is FCM.

列明C.R. Bard, 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。

K253514明尼苏达四腔食管胃填塞管 - 18 French (0092220)；布莱克莫尔食管鼻胃管 - 20 French (0092100)；布莱克莫尔食管鼻胃管 - 16 French (0092300)K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864橡胶通用导管 K251186Bard® 临时起搏电极导管针/管 (引入器)K241334半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，4Fr.（006221P）；半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，5Fr.（006225P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，6Fr.（006241P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，7Fr.（006242P）；NBIH™临时起搏电极导管 K230356Aspirex™ 血栓切除术系统

查看所有 67 个设备 →

相关器械（代码：FCM）

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。

K250891Cure 管道插入套装（K1）；Cure 管道插入套装（K2）；Cure 管道插入套装（K2-90）；Cure 管道插入套装（K3）；Cure 润滑性导管套装（HM12UK）；Cure 润滑性导管套装（HM14UK）；Cure 润滑性导管套装（HM16UK）；Cure 口袋导管套装（M14UK）；Cure 管道闭合系统套装（CS8）；Cure 管道闭合系统套装（CS10）；Cure 管道闭合系统套装（CS12）；Cure 管道闭合系统套装（CS14）；Cure 管道闭合系统套装（CS14C）Convatec Limited K223821自用闭式导尿系统Coloplast

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。