Maestro System (REF100)— 510(k) K250984

Substantially Equivalent

Moon Surgical

FDA 510(k) clearance K250984 for Maestro System (REF100), Substantially Equivalent on 2025-06-27. Applicant: Moon Surgical. Device class: 2.

Clearance details

Applicant: Moon Surgical
Product code: Code QZB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-03-31
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QZB

K261573 — ENDOSCOPE HOLDER (182214)2026-07-20
K242323 — Maestro System (REF100)2025-03-14
K233312 — SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499) +2 more2024-08-08

More clearances from Moon Surgical

K240598 — Maestro System (REF100)2024-06-03
K221410 — Maestro Platform2022-12-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.