SCOUT MD Surgical Guidance System— 510(k) K231468
Substantially EquivalentMerit Medical System, Inc.
FDA 510(k) clearance K231468 for SCOUT MD Surgical Guidance System, Substantially Equivalent on 2024-02-12. Applicant: Merit Medical System, Inc..
Clearance details
- Applicant
- Merit Medical System, Inc.
- Product code
- Code NEU
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Adverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
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.