FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
K Number: K873360
·
Decision Mar 30, 1988
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
37
Review Days
222
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Basic Information
- Device Name
- ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
- K Number
- K873360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Endovations
- Date Received
- August 21, 1987
- Decision Date
- March 30, 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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| K892218 | ENDO-SPONGE | May 31, 1989 | Substantially Equivalent |
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| K875264 | WASHING CATHETER | Mar 29, 1988 | Substantially Equivalent |
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