The following data is part of a premarket notification filed by G.u.-tek with the FDA for Continuous Flow Y-tubing.
| Device ID | K010122 |
| 510k Number | K010122 |
| Device Name: | CONTINUOUS FLOW Y-TUBING |
| Classification | System, Irrigation, Urological |
| Applicant | G.U.-TEK 904 OAK TREE AVE. South Plainfield, NJ 07080 |
| Contact | Anthony Solazzo |
| Correspondent | Anthony Solazzo G.U.-TEK 904 OAK TREE AVE. South Plainfield, NJ 07080 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-16 |
| Decision Date | 2001-06-04 |