The following data is part of a premarket notification filed by Convatec Limited with the FDA for Gentlecath Glide Intermittent Catheter.
| Device ID | K161344 |
| 510k Number | K161344 |
| Device Name: | GentleCath Glide Intermittent Catheter |
| Classification | Catheter, Urological |
| Applicant | CONVATEC LIMITED GDC, FIRST AVENUE, DEESIDE INDUSTRIAL PARK Deeside, GB Ch5 2nu |
| Contact | Elinor Jones |
| Correspondent | Elinor Jones CONVATEC LIMITED GDC, 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 | 2016-05-13 |
| Decision Date | 2016-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455205646 | K161344 | 000 |
| 00768455145515 | K161344 | 000 |
| 00768455205318 | K161344 | 000 |
| 00768455202249 | K161344 | 000 |
| 00768455205332 | K161344 | 000 |
| 00768455205356 | K161344 | 000 |
| 00768455202287 | K161344 | 000 |
| 00768455202294 | K161344 | 000 |
| 00768455202300 | K161344 | 000 |
| 00768455205400 | K161344 | 000 |
| 00768455205417 | K161344 | 000 |
| 00768455202522 | K161344 | 000 |
| 00768455202539 | K161344 | 000 |
| 00768455202553 | K161344 | 000 |
| 00768455145508 | K161344 | 000 |