FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHEATH, ENDOSCOPE
K Number: K862059
·
Decision Nov 4, 1986
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
37
Review Days
158
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Basic Information
- Device Name
- SHEATH, ENDOSCOPE
- K Number
- K862059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Endovations
- Date Received
- May 30, 1986
- Decision Date
- November 4, 1986
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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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 |