UROCURE, LLC

FDA Device Registration & Listing · Norcross, GA, US · Registration 3013859837

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
3013859837
FEI Number
3013859837
Entity Name
UROCURE, LLC
City/State/Country
Norcross, GA, US
Establishment Address
1856 Corporate Dr Ste 135, Norcross, GA 30093, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
UroCure, LLC (Owner Number: 10061024)
Owner / Operator Contact Address
1856 Corporate Drive, Suite 135, Norcross, GA 30093, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222468
PMA Number
N/A

All Registered Proprietary Names

ArcSP ArcTO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2022-12-09
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2022-12-09

Official Correspondent

Pawel Lukaszewicz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UroCure, LLC
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
K222293 Urocure, LLC ArcSP Suprapubic Sling System 2022-09-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013859837. Last updated year: 2026. Please use registration number 3013859837 when referencing this establishment in official correspondence.
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