K232518 is an FDA 510(k) clearance for the EndoSound Vision System; EVS, a Endoscopic Ultrasound System, Gastroenterology-urology (Class II — Special Controls, product code ODG), submitted by Endosound, Inc. (Portland, US). The FDA issued a Cleared decision on December 27, 2023, 131 days after receiving the submission on August 18, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K232518 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 2023 |
| Decision Date | December 27, 2023 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODG — Endoscopic Ultrasound System, Gastroenterology-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |