BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit— 510(k) K254076
UnknownC.R. Bard, Inc.
FDA 510(k) clearance K254076 for BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit, Unknown on 2026-05-29. Applicant: C.R. Bard, Inc.. Device class: 2.
Summary
C.R. Bard's BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit is filed under FCM, sterile urethral catheterization trays, with or without catheter (kit).
Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Bard filed from Covington, Georgia. The decision came 162 calendar days after receipt (December 18, 2025 to May 29, 2026).
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Product code FCM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Covington, GA, US
Recent devices under product code FCM
view allMore clearances from C.R. Bard, Inc.
view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) +4 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.