FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETERAL STENT
K Number: K852389
·
Decision Sep 5, 1985
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
72
Review Days
92
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Basic Information
- Device Name
- URETERAL STENT
- K Number
- K852389
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Medical Systems, Inc.
- Date Received
- June 5, 1985
- Decision Date
- September 5, 1985
- Product Code
- FAD
- 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | FDA class 2 | Gastroenterology, Urology |
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