The following data is part of a premarket notification filed by Convatec Limited with the FDA for Gentlecath Glide Intermittent Urinary Catheter.
| Device ID | K181206 |
| 510k Number | K181206 |
| Device Name: | GentleCath Glide Intermittent Urinary Catheter |
| Classification | Catheter, Urethral |
| Applicant | ConvaTec Limited GDC, First Avenue, Deepside Industrial Park Deeside, GB Ch5 2nu |
| Contact | Elinor Jones |
| Correspondent | Elinor Jones ConvaTec Limited GDC, First Avenue, Deepside Industrial Park Deeside, GB Ch5 2nu |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70768455153847 | K181206 | 000 |
| 00768455168675 | K181206 | 000 |
| 00768455169009 | K181206 | 000 |
| 00768455168651 | K181206 | 000 |
| 00768455168644 | K181206 | 000 |
| 00768455168613 | K181206 | 000 |
| 00768455168941 | K181206 | 000 |
| 00768455168590 | K181206 | 000 |
| 00768455168927 | K181206 | 000 |
| 00768455168910 | K181206 | 000 |
| 00768455168569 | K181206 | 000 |
| 00768455168545 | K181206 | 000 |
| 00768455168873 | K181206 | 000 |
| 00768455169023 | K181206 | 000 |
| 00768455169030 | K181206 | 000 |
| 00768455168965 | K181206 | 000 |
| 70768455153830 | K181206 | 000 |
| 70768455153823 | K181206 | 000 |
| 70768455153816 | K181206 | 000 |
| 70768455153809 | K181206 | 000 |
| 70768455153793 | K181206 | 000 |
| 50768455153812 | K181206 | 000 |
| 00768455202546 | K181206 | 000 |
| 00768455205592 | K181206 | 000 |
| 00768455205394 | K181206 | 000 |
| 00768455205349 | K181206 | 000 |
| 00768455143016 | K181206 | 000 |
| 10768455157157 | K181206 | 000 |
| 00768455168552 | K181206 | 000 |