FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K Number: K882867
·
Decision Sep 21, 1988
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
21
Review Days
72
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Basic Information
- Device Name
- CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
- K Number
- K882867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Corpak Co.
- Date Received
- July 11, 1988
- Decision Date
- September 21, 1988
- 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 Corpak Co.
| K Number | Device Name | ||
|---|---|---|---|
| K935512 | CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE | Aug 29, 1996 | Substantially Equivalent |
| K931921 | CORPAK GASTROSTOMY TUBE | Jun 9, 1995 | Substantially Equivalent |
| K932847 | CORPAK ENTERAL PUMP | Jun 17, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K902949 | CORPAK GRASPING FORCEPS | Aug 30, 1990 | Substantially Equivalent |
| K901501 | CORPAK GASTROSTOMY TUBE | Jun 11, 1990 | Substantially Equivalent |
| K853253 | CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI | Nov 5, 1985 | Substantially Equivalent |
| K852792 | CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW | Aug 8, 1985 | Substantially Equivalent |
| K842257 | CORPAK URINARY DRAINAGE BAG | Aug 8, 1984 | Substantially Equivalent |
| K841819 | CORPAK FOLEY CATH TRAY W/16FR. TEFLON | Jul 19, 1984 | Substantially Equivalent |
| K840292 | URETHRAL CATH. TRAY W/BAG | Mar 16, 1984 | Substantially Equivalent |