Conseal(Tm) Colostomy Continence System
FDA 510(k) K863830 · Coloplast A/S
510(k) numberK863830
Submission
- Device name
- Conseal(Tm) Colostomy Continence System
- Applicant
- Coloplast A/S
Fort Woth, TX, US - Received
- September 30, 1986
- Decision date
- October 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K102536 | Vitala Continence Control DeviceEZQ · Traditional | Convatec, Inc. | 12/01/2010SE |
| 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 |
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Questions and answers
When was Conseal(Tm) Colostomy Continence System cleared by the FDA?
Conseal(Tm) Colostomy Continence System (K863830) received a 510(k) decision of Substantially Equivalent on October 16, 1986, 16 days after the submission was received.
What is the product code of K863830?
The FDA product code is EZQ – Pouch, Colostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.