The following data is part of a premarket notification filed by Robling Medical, Inc. with the FDA for United Urologics Closed System Catheter.
| Device ID | K160877 |
| 510k Number | K160877 |
| Device Name: | United Urologics Closed System Catheter |
| Classification | Catheter, Urological |
| Applicant | ROBLING MEDICAL, INC. 90 Weathers Street Youngsville, NC 27596 |
| Contact | Diane Peper |
| Correspondent | Diane Peper ROBLING MEDICAL, INC. 90 Weathers Street Youngsville, NC 27596 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-30 |
| Decision Date | 2016-05-20 |
| Summary: | summary |