Maestro System (REF100)
510(k) K242323
Maestro System (REF100) is a medical device (FDA Class II; FDA product code QZB, Software Controlled Endoscope And Instrument Holder) made by Moon Surgical, Inc., cleared under FDA 510(k) K242323 on 14 Mar 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242323 | Date14 Mar 2025 | StatusActive |
Official records
- FDA 510(k) database K242323
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QZB
- FDA applicant
- Moon Surgical
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K242323
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Maestro System 100 | 100 | 03770025849096 | — | On the market |