Vitala Continence Control Device
FDA 510(k) K102536 · Convatec, Inc.
510(k) numberK102536
Submission
- Device name
- Vitala Continence Control Device
- Applicant
- Convatec, Inc.
Skillman, NJ, US - Received
- September 3, 2010
- Decision date
- December 1, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZQ – Pouch, Colostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111365 | Vitala Continence Control DeviceEZQ · Traditional | Convatec, Inc. | 08/19/2011SE |
| K083785 | Vitala Continence Control DeviceEZQ · Traditional | Convatec | 04/02/2010SE |
| K922401 | 4 Sure TM Colostomy PouchEZQ · Traditional | Boston Pacific Medical, Inc. | 06/10/1992SE |
| K880327 | Marlen Ultra Ileostomy POUCH-5000EZQ · Traditional | Marlen Mfg. & Development Co. | 02/19/1988SE |
| K863830 | Conseal(Tm) Colostomy Continence SystemEZQ · Traditional | Coloplast A/S | 10/16/1986SE |
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| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist…EZD · Traditional | 07/01/2025SE |
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| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…EZD · Traditional | 01/25/2024SE |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed SystemEZD · Traditional | 11/08/2023SESK |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD · Traditional | 11/17/2022SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | 06/22/2022SE |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT · Traditional | 04/30/2019SE |
Questions and answers
When was Vitala Continence Control Device cleared by the FDA?
Vitala Continence Control Device (K102536) received a 510(k) decision of Substantially Equivalent on December 1, 2010, 89 days after the submission was received.
What is the product code of K102536?
The FDA product code is EZQ – Pouch, Colostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.