Fmx G1

by Domain Surgical, Inc.

Fmx G1 (FMG1) is a Class II device made by Domain Surgical, Inc., cleared under FDA 510(k) K110439 on 18 Jul 2011 and listed in FDA GUDID since 8 Jun 2016 (UDI-DI 00859729006004), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00859729006004 UDI-DI	Date8 Jun 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK110439	Date18 Jul 2011Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00859729006004
FDA 510(k) database 510(k) number K110439

Across registries

2 registries list this device

FDA 510(k) K110439 decided 18 Jul 2011 Active
FDA GUDID UDI-DI 00859729006004 listed 8 Jun 2016 Listed

Timeline

2 dated events

18 Jul 2011 Cleared FDA 510(k) K110439
8 Jun 2016 Listed FDA GUDID 00859729006004

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Fmx
Generic name: Electrosurgical system generator
Model / Ref / Catalog: G1, FMG1

Primary DI / UDI-DI: 00859729006004
510(k) Number: K110439
FDA product code: GEI
GMDN term: Electrosurgical system generator

Device class: Class II
Regulation number: 878.4400
GUDID distribution status: In Commercial Distribution

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Properties

Serial number
Manufacturing date

Other properties (13, all answered No)