The following data is part of a premarket notification filed by Convatec Limited with the FDA for Gentlecath Intermittent Urinary Catheter.
| Device ID | K172924 |
| 510k Number | K172924 |
| Device Name: | GentleCath Intermittent Urinary Catheter |
| Classification | Catheter, Urological |
| Applicant | ConvaTec Limited ConvaTec Limited (GDC) First Avenue, Deepside Industrial Park Deeside, GB Ch5 2nu |
| Contact | Hannah Sharp |
| Correspondent | Hannah Sharp ConvaTec Limited ConvaTec Limited (GDC) First Avenue, Deepside 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 | 2017-09-25 |
| Decision Date | 2017-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455145522 | K172924 | 000 |
| 00768455145454 | K172924 | 000 |
| 00768455145461 | K172924 | 000 |
| 00768455145478 | K172924 | 000 |
| 00768455145485 | K172924 | 000 |
| 00768455145492 | K172924 | 000 |
| 00768455145508 | K172924 | 000 |
| 00768455145515 | K172924 | 000 |
| 00768455145539 | K172924 | 000 |
| 00768455145546 | K172924 | 000 |
| 00768455145553 | K172924 | 000 |
| 00768455145560 | K172924 | 000 |
| 00768455145577 | K172924 | 000 |
| 00768455145584 | K172924 | 000 |
| 00768455145591 | K172924 | 000 |
| 00768455145607 | K172924 | 000 |
| 00768455145447 | K172924 | 000 |