BARD V-MAX ROLLER BAR (3551XX; XX=01,02,03,04,05, OR 06)— 510(k) K961841

Clearance details

Device name as filed

BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)

Applicant

C.R. Bard, Inc.

Product code

Code FAS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

1996-05-13

Decision date

1996-10-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Covington, GA, US

• K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )2025-12-05
• K250522 — Multi4 System2025-06-27
• K240504 — PLASMA EDGE System2024-06-12
• K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge2022-03-02
• K210651 — Resection Electrodes with HF cable2021-08-03

• K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more2026-07-10
• K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit2026-05-29
• K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)2026-03-17
• K251864 — Rubber Utility Catheter2026-02-23
• K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)2025-05-15

Death

3

Injury

344

Malfunction

1,130

Total

1,477

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →