FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAL FIBER OPTIC URETERAL TRANSILLUMIN
K Number: K834576
·
Decision Apr 20, 1984
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
25
Applicant Total
1
Review Days
113
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- REAL FIBER OPTIC URETERAL TRANSILLUMIN
- K Number
- K834576
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Douglas Manufacturer Co.
- Date Received
- December 29, 1983
- Decision Date
- April 20, 1984
- Product Code
- FFS
- 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 |
|---|---|---|---|
| FFS | Image, Illumination, Fiberoptic, For Endoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFS), ordered by most recent decision date.
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PS SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRU-CABLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCUTECH ENDOLITE PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOVIS OPTIQUE'S ENDOSCOPIC CABLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology