FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT FEEDING TUBES
K Number: K020005
·
Decision Jul 16, 2002
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
16
Review Days
195
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Basic Information
- Device Name
- INFANT FEEDING TUBES
- K Number
- K020005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promedic, Inc.
- Date Received
- January 2, 2002
- Decision Date
- July 16, 2002
- 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 Promedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131889 | EUM 100PRO | Apr 23, 2014 | Substantially Equivalent |
| K112318 | CLEARPATH 24 | Jun 29, 2012 | Substantially Equivalent |
| K072756 | NON-IV ADAPTER FOR INFANT NG TUBE | Dec 19, 2007 | Unknown |
| K060497 | BABYAIR | Jul 11, 2006 | Substantially Equivalent |
| K060842 | REVJET TURBO | Jun 21, 2006 | Substantially Equivalent |
| K052903 | PEDIATRIC FEEDING TUBE | Nov 9, 2005 | Substantially Equivalent |
| K031409 | URINARY CATHETERS | Jun 17, 2003 | Substantially Equivalent |
| K024190 | FENESTRATED INFUSION CATHETER | Mar 17, 2003 | Substantially Equivalent |
| K023579 | GAS SAMPLING LINES | Jan 28, 2003 | Substantially Equivalent |
| K970102 | FILTER | Jun 24, 1997 | Substantially Equivalent |