Maestro System (REF100)
FDA 510(k) clearance K242323 · decided 2025-03-14
Clearance details
- K-number
- K242323
- Device name
- Maestro System (REF100)
- Applicant
- Moon Surgical
- Decision
- Substantially Equivalent
- Date received
- 2024-08-06
- Decision date
- 2025-03-14
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- QZB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Moon Surgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENDOSCOPE HOLDER (182214) (K261573) | Aktormed GmbH | 2026-07-20 |
| Maestro System (REF100) (K250984) | Moon Surgical | 2025-06-27 |
| SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 (K233312) | Aktormed GmbH | 2024-08-08 |
Recalls involving this device
No recalls on record reference this clearance.