The following data is part of a premarket notification filed by Robling Medical with the FDA for United Urologics Intermittent Catheter.
| Device ID | K160795 |
| 510k Number | K160795 |
| Device Name: | United Urologics Intermittent Catheter |
| Classification | Catheter, Urethral |
| Applicant | ROBLING MEDICAL 90 WEATHERS STREET Youngsville, NC 27596 |
| Contact | Diane Peper |
| Correspondent | Diane Peper ROBLING MEDICAL 90 WEATHERS STREET Youngsville, NC 27596 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-23 |
| Decision Date | 2016-06-16 |
| Summary: | summary |