FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ureteric Catheters
K Number: K182122
·
Decision Oct 4, 2018
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
27
Applicant Total
54
Review Days
59
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Basic Information
- Device Name
- Ureteric Catheters
- K Number
- K182122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- August 6, 2018
- Decision Date
- October 4, 2018
- Product Code
- EYB
- 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 |
|---|---|---|---|
| EYB | Catheter, Ureteral, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Oct 26, 2023 | Substantially Equivalent |