FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
ENTERON ABDOMINAL PARACENTESIS TRAY
K Number: K874063
·
Decision Dec 4, 1987
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
37
Review Days
60
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Basic Information
- Device Name
- ENTERON ABDOMINAL PARACENTESIS TRAY
- K Number
- K874063
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Endovations
- Date Received
- October 5, 1987
- Decision Date
- December 4, 1987
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Endovations
| K Number | Device Name | ||
|---|---|---|---|
| K955413 | ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER | Feb 8, 1996 | Substantially Equivalent |
| K942110 | INJECT-SNARE | Oct 13, 1994 | Substantially Equivalent |
| K934315 | ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME | Feb 28, 1994 | Substantially Equivalent |
| K913841 | 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH | Oct 8, 1991 | Substantially Equivalent |
| K913870 | 5MM MICROSCISSORS | Sep 16, 1991 | Substantially Equivalent |
| K911155 | OVAL CUP BIOPSY FORCEP | Aug 7, 1991 | Substantially Equivalent |
| K892218 | ENDO-SPONGE | May 31, 1989 | Substantially Equivalent |
| K883093 | TRANSENDOSCOPIC ASPIRATION NEEDLE | Dec 8, 1988 | Substantially Equivalent |
| K873360 | ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG | Mar 30, 1988 | Substantially Equivalent |
| K875264 | WASHING CATHETER | Mar 29, 1988 | Substantially Equivalent |