The following data is part of a premarket notification filed by Convatec Ltd. with the FDA for Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter.
| Device ID | K140953 |
| 510k Number | K140953 |
| Device Name: | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER |
| Classification | Catheter, Urological |
| Applicant | CONVATEC LTD. UNIT 20, FIRST AVENUE, DEESIDE INDUSTRIAL PARK Deeside, GB Ch5 2nu |
| Contact | Clare Williamson |
| Correspondent | Clare Williamson CONVATEC LTD. UNIT 20, FIRST AVENUE, DEESIDE INDUSTRIAL PARK Deeside, GB Ch5 2nu |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-08-01 |
| Summary: | summary |