Data / Medical devices / United States / Urocure, LLC
Urocure, LLC: FDA-registered device maker in Norcross, GA, United States, 3 510(k) clearances
Urocure, LLC is registered with the FDA (registration 3013859837) in Norcross, GA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated September 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013859837
- Address
- 1856 Corporate Dr Ste 135, Norcross, GA, United States, 30093
- Owner or operator
- UroCure, LLC (10061024)
- Roles
- Specification developer
- First device listed
- July 31, 2019
- Registered through
- 2026
- Brand names listed
- ArcSP, ArcTO, ArcTV Transvaginal Sling System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | 2 | 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 21, 2022 | K222293 | ArcSP Suprapubic Sling System | OTN | Substantially Equivalent | Urocure, LLC | accessdata.fda.gov |
| September 15, 2022 | K222468 | ArcTO Transobturator Sling System | OTN | Substantially Equivalent | Urocure, LLC | accessdata.fda.gov |
| February 7, 2019 | K183134 | ArcTV Transvaginal Sling System | OTN | Substantially Equivalent | Urocure, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 21, 2022. 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.