FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
M-LENS (THIRTY DEGREE ENDOSCOPE)
K Number: K873795
·
Decision Jan 14, 1988
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
1
Applicant Total
2
Review Days
119
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Basic Information
- Device Name
- M-LENS (THIRTY DEGREE ENDOSCOPE)
- K Number
- K873795
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Opto Vision, Inc.
- Date Received
- September 17, 1987
- Decision Date
- January 14, 1988
- Product Code
- FEI
- 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 |
|---|---|---|---|
| FEI | Instrument, Special Lens, For Endoscope | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FEI), ordered by most recent decision date.
View allOther Clearances by Opto Vision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892145 | FIBER OPTIC LIGHT TRANSMISSION CABLE | Sep 29, 1989 | Substantially Equivalent |