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FDA 510(k)

CERVEX-BRUSH COMBI

K-Number: K043369 · 2005-02-02

ApplicantRovers Medical Devices B.V.
Decision Date2005-02-02
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERVEX-BRUSH COMBI is the device name listed in this FDA 510(k) record. The listed applicant is Rovers Medical Devices B.V.. It received FDA 510(k) clearance on 2005-02-02 under 510(k) number K043369. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVEX-BRUSH COMBI?

CERVEX-BRUSH COMBI is a medical device that received FDA 510(k) clearance on 2005-02-02. The listed applicant is Rovers Medical Devices B.V.. The 510(k) number is K043369.

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

CERVEX-BRUSH COMBI received FDA 510(k) clearance on 2005-02-02, under 510(k) number K043369.

Who is the listed applicant for CERVEX-BRUSH COMBI?

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

What is the FDA product code for CERVEX-BRUSH COMBI?

The FDA product code for CERVEX-BRUSH COMBI is HHT.

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 Medical Devices B.V. 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.

K002520ROVERS SPATULAK001119ROVERS ENDOCERVEX-BRUSH

Related Devices (Code: HHT)

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.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, 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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