FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WASHING CATHETER
K Number: K875264
·
Decision Mar 29, 1988
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
90
Applicant Total
37
Review Days
98
Basic Information
- Device Name
- WASHING CATHETER
- K Number
- K875264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- ENDOVATIONS
- Date Received
- December 22, 1987
- Decision Date
- March 29, 1988
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCX), ordered by most recent decision date.
ArgoCap (200.52)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoscopic Water Pump
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Water Container (MAJ-901); Water Container (MAJ-902)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Aspiration Catheter (2189)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearCap Distal Attachment
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
troCarWash System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K874062 | ENTERON LIVER BIOPSY TRAY | Dec 31, 1987 | Substantially Equivalent |