FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
K Number: K180469
·
Decision Nov 6, 2018
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
54
Review Days
258
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Basic Information
- Device Name
- ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
- K Number
- K180469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- February 21, 2018
- Decision Date
- November 6, 2018
- 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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