FDA 510(k)
Substantially Equivalent
🇺🇸 United States
FLEXIBLE FIBEROPTIC ENDOSCOPE
K Number: K850393
·
Decision Jun 4, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
18
Review Days
123
Basic Information
- Device Name
- FLEXIBLE FIBEROPTIC ENDOSCOPE
- K Number
- K850393
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- MICROVASIVE
- Date Received
- February 1, 1985
- Decision Date
- June 4, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Other Clearances by MICROVASIVE
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|---|---|---|---|
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| K861323 | REPLACEMENT GASTROSTOMY TUBE | Dec 16, 1986 | Substantially Equivalent |
| K861309 | JEJUNAL FEEDING TUBE | Dec 16, 1986 | Substantially Equivalent |
| K860366 | CHALLENGER HOT BIOPSY FORCEPS | Apr 7, 1986 | Substantially Equivalent |
| K860589 | INFLATOR/DEFLATOR PISTON SYRINGE | Apr 7, 1986 | Substantially Equivalent |
| K854238 | NEEDLE W/STYLET FOR IMPLANTATION | Nov 13, 1985 | Substantially Equivalent |
| K854063 | MICROVASIVE SILICONE SPRAY | Oct 25, 1985 | Substantially Equivalent |
| K851652 | PAPILLOTOME | Jun 24, 1985 | Substantially Equivalent |
| K844769 | RIGID FIBEROPITC ENDOSCOPE | Jan 15, 1985 | Substantially Equivalent |