FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE STEERABLE ANGIOSCOPE
K Number: K931421
·
Decision Jun 16, 1993
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
40
Applicant Total
3
Review Days
86
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Basic Information
- Device Name
- DISPOSABLE STEERABLE ANGIOSCOPE
- K Number
- K931421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endovascular, Inc.
- Date Received
- March 22, 1993
- Decision Date
- June 16, 1993
- Product Code
- LYK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LYK | Angioscope | FDA class 2 | Gastroenterology, Urology |
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