FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GASTRO-ENTEROSTOMY TUBE
K Number: K852707
·
Decision Aug 14, 1985
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
24
Review Days
49
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Basic Information
- Device Name
- GASTRO-ENTEROSTOMY TUBE
- K Number
- K852707
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Innovations Corp.
- Date Received
- June 26, 1985
- Decision Date
- August 14, 1985
- 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 Medical Innovations Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945612 | MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE | Apr 19, 1995 | Substantially Equivalent |
| K940548 | MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE | Feb 22, 1995 | Substantially Equivalent |
| K943685 | MIC DISPOSABLE SNARE | Nov 1, 1994 | Substantially Equivalent |
| K926581 | MIC TRANSGASTRIC JEJUNAL TUBE | Sep 28, 1994 | Substantially Equivalent |
| K921652 | MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT | May 2, 1994 | Unknown |
| K921370 | MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION | May 2, 1994 | Unknown |
| K924065 | MIC PEG TUBE | Feb 17, 1994 | Unknown |
| K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | Dec 1, 1993 | Unknown |
| K913320 | MIL CM-II COAGULATION MACHINE | Jun 16, 1992 | Substantially Equivalent |
| K903531 | ANTICARDIOLIPIN ANTIBODY TEST SYSTEM | Jan 25, 1991 | Substantially Equivalent |