ScopeSeal Duodenoscope Protective Device— 510(k) K183171
Substantially EquivalentGi Scientific, LLC
FDA 510(k) clearance K183171 for ScopeSeal Duodenoscope Protective Device, Substantially Equivalent on 2019-10-08. Applicant: Gi Scientific, LLC.
Clearance details
- Applicant
- Gi Scientific, LLC
- Product code
- Code ODB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, VA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.