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)

VITALA CONTINENCE CONTROL DEVICE

K-Number: K083785 · 2010-04-02

ApplicantConvatec
Decision Date2010-04-02
Product CodeEZQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VITALA CONTINENCE CONTROL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec. It received FDA 510(k) clearance on 2010-04-02 under 510(k) number K083785. The device is classified under product code EZQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALA CONTINENCE CONTROL DEVICE?

VITALA CONTINENCE CONTROL DEVICE is a medical device that received FDA 510(k) clearance on 2010-04-02. The listed applicant is Convatec. The 510(k) number is K083785.

When did VITALA CONTINENCE CONTROL DEVICE receive FDA 510(k) clearance?

VITALA CONTINENCE CONTROL DEVICE received FDA 510(k) clearance on 2010-04-02, under 510(k) number K083785.

Who is the listed applicant for VITALA CONTINENCE CONTROL DEVICE?

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

What is the FDA product code for VITALA CONTINENCE CONTROL DEVICE?

The FDA product code for VITALA CONTINENCE CONTROL DEVICE is EZQ.

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 Convatec 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.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)K243228Flexi-Seal AIR (with ENFit Connector)K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)K162906Flexi-Seal PROTECT Fecal Management SystemK091034AQUACEL AG SURGICAL

View all 8 devices →

Related Devices (Code: EZQ)

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.

K111365VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.K102536VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.K9224014 SURE TM COLOSTOMY POUCHBoston Pacific Medical, Inc.K880327MARLEN ULTRA ILEOSTOMY POUCH-5000Marlen Mfg. & Development Co.K863830CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEMColoplast A/S

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.

↑