FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
GASTROPORT II
K Number: K924308
·
Decision Jul 29, 1993
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
20
Review Days
337
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Basic Information
- Device Name
- GASTROPORT II
- K Number
- K924308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Sandoz Nutrition
- Date Received
- August 26, 1992
- Decision Date
- July 29, 1993
- 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 Sandoz Nutrition
| K Number | Device Name | ||
|---|---|---|---|
| K965087 | COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) | Mar 18, 1997 | Unknown |
| K961664 | COMPAT NASOJEJUNAL FEEDING TUBE | Oct 4, 1996 | Substantially Equivalent |
| K940555 | SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION | Feb 1, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K940556 | SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP | Nov 7, 1994 | Substantially Equivalent |
| K923983 | PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT | Apr 6, 1993 | Substantially Equivalent |
| K915308 | PEG GASTROSTOMY TUBE KIT | Mar 12, 1993 | Unknown |
| K920493 | PEG PREP TRAY | Jan 4, 1993 | Unknown |
| K914492 | GASTROINTESTINAL TUBE AND ACCESSORIES | Feb 25, 1992 | Unknown |
| K915439 | NASOGASTRIC FEEDING TUBE KITS | Feb 25, 1992 | Unknown |
| K913407 | NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE | Feb 25, 1992 | Unknown |