FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDO-SPONGE
K Number: K892218
·
Decision May 31, 1989
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
3
Applicant Total
37
Review Days
58
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Basic Information
- Device Name
- ENDO-SPONGE
- K Number
- K892218
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Endovations
- Date Received
- April 3, 1989
- Decision Date
- May 31, 1989
- Product Code
- MNL
- 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 |
|---|---|---|---|
| MNL | Accessories, Cleaning Brushes, For Endoscope | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNL), ordered by most recent decision date.
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MILL-ROSE SCOPE CLEANING BRUSH
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CLEANING BRUSH
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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 |
| 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 |
| K874062 | ENTERON LIVER BIOPSY TRAY | Dec 31, 1987 | Substantially Equivalent |