The following data is part of a premarket notification filed by Convatec Limited with the FDA for Gentlecath Air For Men Hydrophilic Intermittent Urinary Catheter.
| Device ID | K213283 |
| 510k Number | K213283 |
| Device Name: | GentleCath Air For Men Hydrophilic Intermittent Urinary Catheter |
| Classification | Catheter, Urethral |
| Applicant | ConvaTec Limited GDC, First Avenue, Deeside Industrial Park Deeside, GB CH5 2NU |
| Contact | Louise Hollywood |
| Correspondent | Louise Hollywood ConvaTec Limited GDC, First Avenue, Deeside 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 | 2021-10-01 |
| Decision Date | 2022-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455198948 | K213283 | 000 |
| 00768455196678 | K213283 | 000 |
| 00768455196647 | K213283 | 000 |
| 00768455196616 | K213283 | 000 |
| 00768455196586 | K213283 | 000 |
| 00768455196555 | K213283 | 000 |
| 00768455196340 | K213283 | 000 |
| 00768455196319 | K213283 | 000 |
| 00768455196289 | K213283 | 000 |
| 00768455196258 | K213283 | 000 |
| 00768455196227 | K213283 | 000 |
| 00768455196708 | K213283 | 000 |
| 00768455198436 | K213283 | 000 |
| 00768455198917 | K213283 | 000 |
| 00768455198887 | K213283 | 000 |
| 00768455198856 | K213283 | 000 |
| 00768455198825 | K213283 | 000 |
| 00768455198795 | K213283 | 000 |
| 00768455198580 | K213283 | 000 |
| 00768455198559 | K213283 | 000 |
| 00768455198528 | K213283 | 000 |
| 00768455198498 | K213283 | 000 |
| 00768455198467 | K213283 | 000 |
| 00768455196197 | K213283 | 000 |