FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
K Number: K041995
·
Decision Aug 19, 2004
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
10
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
- K Number
- K041995
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Uresil, LLC
- Date Received
- July 23, 2004
- Decision Date
- August 19, 2004
- Product Code
- GBO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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