Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CERVEX-BRUSH PAP KIT

K-Number: K941472 · 1995-02-28

ApplicantRovers Diagnostic Devices
Decision Date1995-02-28
Product CodeHHT
Advisory CommitteeOB
DecisionUnknown

Device Summary

CERVEX-BRUSH PAP KIT 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 1995-02-28 under 510(k) number K941472. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CERVEX-BRUSH PAP KIT?

CERVEX-BRUSH PAP KIT is a medical device that received FDA 510(k) clearance on 1995-02-28. The listed applicant is Rovers Diagnostic Devices. The 510(k) number is K941472.

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

CERVEX-BRUSH PAP KIT received FDA 510(k) clearance on 1995-02-28, under 510(k) number K941472.

Who is the listed applicant for CERVEX-BRUSH PAP KIT?

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 CERVEX-BRUSH PAP KIT?

The FDA product code for CERVEX-BRUSH PAP KIT 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 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.

K942843CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGYK942144URETHRA-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.

↑