FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Maestro System (REF100)
K Number: K250984
·
Decision Jun 27, 2025
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
4
Review Days
88
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Basic Information
- Device Name
- Maestro System (REF100)
- K Number
- K250984
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Moon Surgical
- Date Received
- March 31, 2025
- Decision Date
- June 27, 2025
- Product Code
- QZB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QZB | Software Controlled Endoscope And Instrument Holder | FDA class 2 | Gastroenterology, Urology |
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