FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONVATEC FECAL MANAGEMENT SYSTEM
K Number: K032734
·
Decision Apr 8, 2004
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
10
Review Days
217
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Basic Information
- Device Name
- CONVATEC FECAL MANAGEMENT SYSTEM
- K Number
- K032734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Convatec, A Bristol-Myers Squibb Co.
- Date Received
- September 4, 2003
- Decision Date
- April 8, 2004
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Convatec, A Bristol-Myers Squibb Co.
| K Number | Device Name | ||
|---|---|---|---|
| K990368 | DUODERM HYDROACTIVE GEL WOUND DRESSING | Mar 26, 1999 | Substantially Equivalent |
| K982116 | AQUACEL HYDROFIBER WOUND DRESSING | Sep 8, 1998 | Substantially Equivalent |
| K973806 | DUODERM HYDROACTIVE GEL | Dec 29, 1997 | Substantially Equivalent for Some Indications |
| K973807 | DUODERM HYDROACTIVE PASTE | Dec 23, 1997 | Substantially Equivalent for Some Indications |
| K973716 | DUODERM EXTRA THIN CGF DRESSING | Dec 17, 1997 | Substantially Equivalent for Some Indications |
| K973717 | COMBIDERM ACD | Dec 17, 1997 | Substantially Equivalent for Some Indications |
| K954918 | COMBIDERM ACD | Dec 26, 1995 | Substantially Equivalent |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | Mar 17, 1995 | Substantially Equivalent |
| K940895 | EPIVIEW | Nov 22, 1994 | Substantially Equivalent for Some Indications |