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Maestro System 100

by Moon Surgical, Inc.

Maestro System 100 is a surgical camera holder (FDA Class II; FDA product code QZB, Software Controlled Endoscope And Instrument Holder) made by Moon Surgical, Inc., cleared under FDA 510(k) K250984 on 27 Jun 2025 (2 earlier submissions) and listed in FDA GUDID since 3 Sep 2024 (UDI-DI 03770025849096), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250984 Date27 Jun 2025DecidedStatusActive
United StatesGUDID listing Number03770025849096 UDI-DI Date3 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250984 decided 27 Jun 2025 Active· +2 more in the status table
  • FDA GUDID UDI-DI 03770025849096 listed 3 Sep 2024 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K240598
  2. Listed FDA GUDID 03770025849096
  3. Cleared FDA 510(k) K242323
  4. Cleared FDA 510(k) K250984

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Maestro System
Generic name
Surgical camera holder
Model / reference
100
Primary DI / UDI-DI
03770025849096
FDA product code
QZB
GMDN term
Surgical camera holder
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code QZB (Software Controlled Endoscope And Instrument Holder).

Other devices from Moon Surgical, Inc.

See all devices from Moon Surgical, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)