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MXL3-Plg-Pgd

by Origio Inc.

MXL3-Plg-Pgd 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 00888937907834), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K041435

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888937907834 UDI-DI Date22 Aug 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041435 Date29 Sep 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041435 decided 29 Sep 2004 Active
  • FDA GUDID UDI-DI 00888937907834 listed 22 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K041435
  2. Listed FDA GUDID 00888937907834

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Assisted reproduction microtool
Model / reference
MXL3-PLG-PGD
Primary DI / UDI-DI
00888937907834
510(k) Number
FDA product code
MQH
GMDN term
Assisted reproduction microtool
Device class
Class II
Regulation number
884.6130
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K041435)

Similar devices

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

Other devices from Origio Inc.

See all devices from Origio Inc. →

Properties

  • Prescription use
Other properties (14, all answered No)