FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOCUSCOPE UNIVERSAL SYSTEM
K Number: K843900
·
Decision Dec 6, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
4
Review Days
64
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
- FOCUSCOPE UNIVERSAL SYSTEM
- K Number
- K843900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Diagnostics, Ca.
- Date Received
- October 3, 1984
- Decision Date
- December 6, 1984
- Product Code
- GDB
- 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 |
|---|---|---|---|
| GDB | Endoscope, Fiber Optic | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDB), ordered by most recent decision date.
DESIGNS FOR VISION FIBEROPTIC LIGHT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEXSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OLYMPUS GF-UM3/EU-M3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FRITCH OPHTHALMIC ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTAX UPPER G.I. FIBERSCOPE, #FG-34
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology