Data / Medical devices / United States / Uresil, LLC
Uresil, LLC: FDA-registered device maker in Skokie, IL, United States, 2 510(k) clearances
Uresil, LLC is registered with the FDA (registration 1450395) in Skokie, IL, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 8, 1998. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1450395
- Address
- 5418 West Touhy Ave., Skokie, IL, United States, 60077
- Owner or operator
- URESIL, LLC (9021454)
- Roles
- Manufacturer
- First device listed
- June 18, 1992
- Registered through
- 2027
- Brand names listed
- Aspiration and Flush Assembly, Chole-Cath, GP General Purpose Drainage Catheter, NEPHRO-STENT Nephro-ureteral Stent Catheter, Nephro-Cath Nephrostomy Drainage Catheter, Optimus, Posi-Stick Introducer Set, Symphony Centesis Drainage Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Bile Collecting | EXF | 2 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Nephrostomy | LJE | U | Manufacturer | accessdata.fda.gov |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | 1 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 8, 1998 | K980889 | URESIL NEPHRO-URETERAL STENT | LJE | Substantially Equivalent | Uresil Corp. | accessdata.fda.gov |
| July 13, 1993 | K923096 | URESIL BILLIARY CATHETER | FGE | Substantially Equivalent | Uresil Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Catheter, Nephrostomy, General & Plastic Surgery
- All makers of Catheter, Nephrostomy
- All makers of Tape And Bandage, Adhesive
- All makers of Bag, Bile Collecting
- All makers of Bottle, Collection, Vacuum
Updated April 8, 1998. 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.