InnoCare Urologics

FDA Device Registration & Listing · Miami, FL, US · Registration 3027547323

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027547323
FEI Number
3027547323
Entity Name
InnoCare Urologics
City/State/Country
Miami, FL, US
Establishment Address
7175 SW 47TH STREET, Suite 207, Miami, FL 33155, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
InnoCare Urologics (Owner Number: 10088357)
Owner / Operator Contact Address
7175 SW 47TH STREET, Suite 207, Miami, FL 33155, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241424
PMA Number
N/A

All Registered Proprietary Names

Egress Safety Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2024-12-26
SCT Foley Catheters And Accessories With Additional Safety Features Gastroenterology, Urology Class 2 876.5130 2024-12-26

Official Correspondent

Patrick McCain

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

InnoCare Urologics
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027547323. Last updated year: 2026. Please use registration number 3027547323 when referencing this establishment in official correspondence.
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