K241595 is an FDA 510(k) clearance for the EzVu Visual Vasopressor injector (EV-19). This device is classified as a Endoscopic Injection Needle, Gastroenterology-urology (Class II - Special Controls, product code FBK).
Submitted by Veol Medical Technologies Pvt , Ltd. (Navi Mumbai, IN). The FDA issued a Cleared decision on February 27, 2025, 269 days after receiving the submission on June 3, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 876.1500. Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue..
| 510(k) Number | K241595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2024 |
| Decision Date | February 27, 2025 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | FBK - Endoscopic Injection Needle, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue. |