FDA 510(k)

BARD URETEROSCOPIC CYTOLOGY BRUSH

K-Number: K844561 · 1985-01-08

Decision Date1985-01-08

Product CodeFDX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BARD URETEROSCOPIC CYTOLOGY BRUSH 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 1985-01-08 under 510(k) number K844561. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD URETEROSCOPIC CYTOLOGY BRUSH?

BARD URETEROSCOPIC CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K844561.

When did BARD URETEROSCOPIC CYTOLOGY BRUSH receive FDA 510(k) clearance?

BARD URETEROSCOPIC CYTOLOGY BRUSH received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844561.

Who is the listed applicant for BARD URETEROSCOPIC CYTOLOGY BRUSH?

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 BARD URETEROSCOPIC CYTOLOGY BRUSH?

The FDA product code for BARD URETEROSCOPIC CYTOLOGY BRUSH is FDX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing C.R. Bard, Inc. as applicant

K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility Catheter K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

View all 616 devices →

Related Devices (Code: FDX)

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K191485Deflectable Brush Biopsy SetCook Incorporated K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.

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.