InnoCare Specialty Foley Catheter
FDA 510(k) clearance K241424 · decided 2024-09-18
Clearance details
- K-number
- K241424
- Device name
- InnoCare Specialty Foley Catheter
- Applicant
- Innocare Urologics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-05-20
- Decision date
- 2024-09-18
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.