The following data is part of a premarket notification filed by Uresil, Llc with the FDA for Gp General Purpose Drainage Catheter; Mini-pig Drainage Catheter; Nephrostomy Catheter; Biliary Catheter.
| Device ID | K053245 |
| 510k Number | K053245 |
| Device Name: | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | URESIL, LLC 5418 WEST TOUHY AVE. Skokie, IL 60077 |
| Contact | Matthew Mahon |
| Correspondent | Matthew Mahon URESIL, LLC 5418 WEST TOUHY AVE. Skokie, IL 60077 |
| Product Code | FGE |
| Subsequent Product Code | GBO |
| Subsequent Product Code | GBX |
| Subsequent Product Code | LJE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-21 |
| Decision Date | 2005-12-20 |