FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K Number: K972102
·
Decision Jan 23, 1998
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
5
Review Days
233
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Basic Information
- Device Name
- RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
- K Number
- K972102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radius Intl., Inc.
- Date Received
- June 4, 1997
- Decision Date
- January 23, 1998
- 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 Radius Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972025 | RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | Jan 23, 1998 | Substantially Equivalent |
| K971901 | RADIUS LOW PROFILE GASTROSTOMY TUBE KIT | Jan 22, 1998 | Substantially Equivalent |
| K951560 | RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) | Apr 17, 1995 | Substantially Equivalent |
| K930510 | RADIUS ENTERAL FEEDING TUBE | Feb 1, 1995 | Substantially Equivalent |