K181814 is an FDA 510(k) clearance for the AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on September 4, 2018, 57 days after receiving the submission on July 9, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K181814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2018 |
| Decision Date | September 04, 2018 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |