Data / Medical devices / United States / InnoCare Urologics
InnoCare Urologics: FDA-registered device maker in Miami, FL, United States, 1 510(k) clearance
InnoCare Urologics is registered with the FDA (registration 3027547323) in Miami, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027547323
- Address
- 7175 SW 47TH STREET Suite 207, Miami, FL, United States, 33155
- Owner or operator
- InnoCare Urologics (10088357)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 26, 2024
- Registered through
- 2026
- Brand names listed
- Egress Safety Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Foley Catheters And Accessories With Additional Safety Features | SCT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2024 | K241424 | InnoCare Specialty Foley Catheter | EZL | Substantially Equivalent | Innocare Urologics, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.