SKOUT system— 510(k) K253664
Substantially EquivalentIterative Health
FDA 510(k) clearance K253664 for SKOUT system, Substantially Equivalent on 2025-12-22. Applicant: Iterative Health.
Clearance details
- Applicant
- Iterative Health
- Product code
- Code QNP
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cambridge, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.