FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTERNAL FEEDING TUBE-POLYURETHANE EF504
K Number: K844175
·
Decision Jan 2, 1985
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
20
Review Days
69
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Basic Information
- Device Name
- ENTERNAL FEEDING TUBE-POLYURETHANE EF504
- K Number
- K844175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Exco, Inc.
- Date Received
- October 25, 1984
- Decision Date
- January 2, 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 Exco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844203 | ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 | Jan 2, 1985 | Substantially Equivalent |
| K844174 | FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI | Dec 7, 1984 | Substantially Equivalent |
| K832628 | VYGON THORACIC DRAINAGE-VARIOUS #'S | Jan 30, 1984 | Substantially Equivalent |
| K831802 | LIFE VAC #2191 & 2192 | Jan 11, 1984 | Substantially Equivalent |
| K833079 | CENTRACATH #130,135 & 137-HEMOCATH # | Dec 29, 1983 | Substantially Equivalent |
| K830910 | MANOMETER SET C.V.P. #S 298/299 | Apr 5, 1983 | Substantially Equivalent |
| K822879 | ENTERAL NUTRITION 1 | Nov 16, 1982 | Substantially Equivalent |
| K822691 | VYGON EPIDURAL ANAESTHESIA TRAY | Oct 15, 1982 | Substantially Equivalent |
| K822836 | MICROFLEX-VENOFLUX | Oct 15, 1982 | Substantially Equivalent |
| K822724 | SUCTION TUBES | Oct 13, 1982 | Substantially Equivalent |