MXL3-Plg

MXL3-Plg is a Class II device made by Origio Inc., cleared under FDA 510(k) K041435 on 29 Sep 2004 and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 20888937907814), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number20888937907814 UDI-DI	Date22 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK041435	Date29 Sep 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 20888937907814
FDA 510(k) database 510(k) number K041435

Across registries

2 registries list this device

FDA 510(k) K041435 decided 29 Sep 2004 Active
FDA GUDID UDI-DI 20888937907814 listed 22 Aug 2016 Listed

Timeline

2 dated events

29 Sep 2004 Cleared FDA 510(k) K041435
22 Aug 2016 Listed FDA GUDID 20888937907814

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Assisted reproduction microtool
Model / reference: MXL3-PLG

Primary DI / UDI-DI: 20888937907814
510(k) Number: K041435
FDA product code: MQH
GMDN term: Assisted reproduction microtool

Device class: Class II
Regulation number: 884.6130
GUDID distribution status: In Commercial Distribution

Similar devices

Other devices filed under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)).

Other devices from Origio Inc.

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See all devices from Origio Inc. →

Properties

Prescription use

Other properties (14, all answered No)