FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINARY CATHETERS
K Number: K031409
·
Decision Jun 17, 2003
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
16
Review Days
43
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Basic Information
- Device Name
- URINARY CATHETERS
- K Number
- K031409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promedic, Inc.
- Date Received
- May 5, 2003
- Decision Date
- June 17, 2003
- Product Code
- GBM
- 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 |
|---|---|---|---|
| GBM | Catheter, Urethral | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K060497 | BABYAIR | Jul 11, 2006 | Substantially Equivalent |
| K060842 | REVJET TURBO | Jun 21, 2006 | Substantially Equivalent |
| K052903 | PEDIATRIC FEEDING TUBE | Nov 9, 2005 | Substantially Equivalent |
| K024190 | FENESTRATED INFUSION CATHETER | Mar 17, 2003 | Substantially Equivalent |
| K023579 | GAS SAMPLING LINES | Jan 28, 2003 | Substantially Equivalent |
| K020005 | INFANT FEEDING TUBES | Jul 16, 2002 | Substantially Equivalent |
| K970102 | FILTER | Jun 24, 1997 | Substantially Equivalent |