K161344 is an FDA 510(k) clearance for the GentleCath Glide Intermittent Catheter. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on September 20, 2016, 130 days after receiving the submission on May 13, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K161344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2016 |
| Decision Date | September 20, 2016 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD - Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |