FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLOPLAST OSTOMY ROD, MODEL 12814
K Number: K052229
·
Decision Oct 13, 2006
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
1
Applicant Total
54
Review Days
423
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Basic Information
- Device Name
- COLOPLAST OSTOMY ROD, MODEL 12814
- K Number
- K052229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4270
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- August 16, 2005
- Decision Date
- October 13, 2006
- Product Code
- EZP
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EZP | Rod, Colostomy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZP), ordered by most recent decision date.
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