510(k) K242323
- Device
- Maestro System (REF100)
- Applicant
- Moon Surgical
- 510(k) number
- K242323
- Product code
- QZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-14
- Date received
- 2024-08-06
- Regulation
- 876.1500
- Classification name
- Software Controlled Endoscope And Instrument Holder
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Anne Osdoit
- Address
- 9 Rue D'Enghien Paris FR 75010 75010
FDA Registration Numbers#
- 3011390076
- 3033118964
- 3026790309