FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Silicone Foley Catheter for single use
K Number: K172807
·
Decision Jun 4, 2018
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
127
Applicant Total
1
Review Days
259
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Basic Information
- Device Name
- Silicone Foley Catheter for single use
- K Number
- K172807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Changzhou Rongxin Medicine Minimal Invasion Technology
- Date Received
- September 18, 2017
- Decision Date
- June 4, 2018
- 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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