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FDA 510(k)

URETHRA-BRUSH

K-Number: K942144 · 1994-06-27

ApplicantRovers Diagnostic Devices
Decision Date1994-06-27
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHRA-BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Rovers Diagnostic Devices. It received FDA 510(k) clearance on 1994-06-27 under 510(k) number K942144. 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 URETHRA-BRUSH?

URETHRA-BRUSH is a medical device that received FDA 510(k) clearance on 1994-06-27. The listed applicant is Rovers Diagnostic Devices. The 510(k) number is K942144.

When did URETHRA-BRUSH receive FDA 510(k) clearance?

URETHRA-BRUSH received FDA 510(k) clearance on 1994-06-27, under 510(k) number K942144.

Who is the listed applicant for URETHRA-BRUSH?

The FDA 510(k) record lists Rovers Diagnostic Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URETHRA-BRUSH?

The FDA product code for URETHRA-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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rovers Diagnostic Devices as applicant

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.

K941472CERVEX-BRUSH PAP KITK942843CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY

Related Devices (Code: FDX)

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.

K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems CorporationK220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K191485Deflectable Brush Biopsy SetCook IncorporatedK182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook IncorporatedK181317Fusion 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.

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