FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUNYON LARGE VOLUME PARACENTESIS KIT
K Number: K970187
·
Decision Feb 14, 1997
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- RUNYON LARGE VOLUME PARACENTESIS KIT
- K Number
- K970187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gi Supply
- Date Received
- January 17, 1997
- Decision Date
- February 14, 1997
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Gi Supply
| K Number | Device Name | ||
|---|---|---|---|
| K191923 | EverLift Submucosal Lifting Agent | Jun 20, 2020 | Substantially Equivalent |
| K031360 | GI SUPPLY BILIARY STENT | Sep 24, 2003 | Substantially Equivalent |
| K012411 | HP-ONE | Sep 25, 2001 | Substantially Equivalent |
| K970186 | GI SUPPLY PARACENTESIS PUMP | Feb 14, 1997 | Substantially Equivalent |
| K944903 | HP-FAST | Apr 20, 1995 | Substantially Equivalent |
| K931044 | OXY-BLOC | Oct 4, 1993 | Substantially Equivalent |
| K915816 | BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY | Mar 27, 1992 | Substantially Equivalent |