Pouch, Colostomy
The Colostomy Pouch (product code EZQ) is a disposable or reusable collection bag attached to a stoma appliance to collect waste from a colostomy. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.5900 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- EZQ
- Device Class
- FDA class 1
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111365 | VITALA CONTINENCE CONTROL DEVICE | Aug 19, 2011 | Substantially Equivalent | Convatec, Inc. |
| K102536 | VITALA CONTINENCE CONTROL DEVICE | Dec 01, 2010 | Substantially Equivalent | Convatec, Inc. |
| K083785 | VITALA CONTINENCE CONTROL DEVICE | Apr 02, 2010 | Substantially Equivalent | Convatec |
| K922401 | 4 SURE TM COLOSTOMY POUCH | Jun 10, 1992 | Substantially Equivalent | Boston Pacific Medical, Inc. |
| K880327 | MARLEN ULTRA ILEOSTOMY POUCH-5000 | Feb 19, 1988 | Substantially Equivalent | Marlen Mfg. & Development Co. |
| K863830 | CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM | Oct 16, 1986 | Substantially Equivalent | Coloplast A/S |
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.