FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBER OPTIC ENDOSCOPE
K Number: K921918
·
Decision Aug 17, 1993
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
17
Applicant Total
3
Review Days
481
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Basic Information
- Device Name
- FIBER OPTIC ENDOSCOPE
- K Number
- K921918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Electro Fiberoptics Corp.
- Date Received
- April 23, 1992
- Decision Date
- August 17, 1993
- Product Code
- GCM
- 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 |
|---|---|---|---|
| GCM | Endoscope, Rigid | FDA class 2 | Gastroenterology, Urology |
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