Silicone Foley Catheter for single use
FDA 510(k) clearance K172807 · decided 2018-06-04
Clearance details
- K-number
- K172807
- Device name
- Silicone Foley Catheter for single use
- Applicant
- Changzhou Rongxin Medicine Minimal Invasion Technology
- Decision
- Substantially Equivalent
- Date received
- 2017-09-18
- Decision date
- 2018-06-04
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jintan City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.