K181445 is an FDA 510(k) clearance for the AMSure Hydrophilic Intermittent Catheter. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on October 1, 2018, 122 days after receiving the submission on June 1, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K181445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2018 |
| Decision Date | October 01, 2018 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD — Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |