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)

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

K-Number: K011031 · 2001-08-03

ApplicantVysis
Decision Date2001-08-03
Product CodeMMW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vysis. It received FDA 510(k) clearance on 2001-08-03 under 510(k) number K011031. The device is classified under product code MMW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT?

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT is a medical device that received FDA 510(k) clearance on 2001-08-03. The listed applicant is Vysis. The 510(k) number is K011031.

When did VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT receive FDA 510(k) clearance?

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT received FDA 510(k) clearance on 2001-08-03, under 510(k) number K011031.

Who is the listed applicant for VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT?

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

What is the FDA product code for VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT?

The FDA product code for VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT is MMW.

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 Vysis 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.

K033982MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TESTK013785UROVYSION BLADDER CANCER RECURRENCE KITK010288ANEUVYSION MULITICOLOR DNA PROBE KITK972200ANEUVYSIONK954214CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KITK962873CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

View all 8 devices →

Related Devices (Code: MMW)

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.

K203245Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03CNucleix , Ltd.K033982MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TESTVysisK021231NMP22 BLADDERCHEK KIT, NMP22 CONTROL KITMatritech, Inc.K013785UROVYSION BLADDER CANCER RECURRENCE KITVysisK974845BTA STAT TEST PRESCRIPTION HOME USEBard Diagnostic Sciences,Inc.K971402BARD BTA TRAK TESTBard Diagnostic Sciences,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.

↑