K163179 is an FDA 510(k) clearance for the Onli Intermittent Catheter. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on January 26, 2017, 73 days after receiving the submission on November 14, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K163179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2016 |
| Decision Date | January 26, 2017 |
| Days to Decision | 73 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GBM — Catheter, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |