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FDA 510(k)

BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

K-Number: K254076 · 2026-05-29

ApplicantC.R. Bard, Inc.
Decision Date2026-05-29
Product CodeFCM
Advisory CommitteeGU
DecisionUnknown

Device Summary

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.

Frequently Asked Questions

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.

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Related Devices (Code: FCM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplast

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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