EndoSound Vision System; EVS— 510(k) K232518
Substantially EquivalentEndosound, Inc.
FDA 510(k) clearance K232518 for EndoSound Vision System; EVS, Substantially Equivalent on 2023-12-27. Applicant: Endosound, Inc.. Device class: 2.
Clearance details
- Applicant
- Endosound, Inc.
- Product code
- Code ODG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
Recent devices under product code ODG
view allMore clearances from Endosound, Inc.
view allAdverse events under product code ODG
product code ODG- Death
- 30
- Injury
- 237
- Malfunction
- 12,387
- Other
- 1
- Total
- 12,655
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.