FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Folysil Silicone Catheter
K Number: K233411
·
Decision Apr 15, 2024
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
127
Applicant Total
54
Review Days
192
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Basic Information
- Device Name
- Folysil Silicone Catheter
- K Number
- K233411
- 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
- October 6, 2023
- Decision Date
- April 15, 2024
- Product Code
- EZL
- 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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | FDA class 2 | Gastroenterology, Urology |
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