# K040837: Multiject Injector and Microglide Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Medicel AG
- Decided: Jun 17, 2004 after 78 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930320 (1994). 4 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961242: Amo Phacoflex II Intersection System, Allergan, Inc. (1996) Summary page 1.
- K003768: Monarch II Iol Delivery System, Alcon Research, Ltd. (2001) Summary page 1.

## Most influential descendants
- K070669: Iol Injector Set (2007), 19 descendants of its own
- K092023: Naviject SUB2-1P, Model: LP604430 (2009), 18 descendants of its own
- K113852: Bausch & Lomb Iol Injector (2012), 12 descendants of its own
- K050638: Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses (2005), 12 descendants of its own
- K060533: Lenstec Intraocular Lens (Iol) Injection System (2006), 11 descendants of its own

## Indications for use
The Medicel MultiJect injector for intraocular lenses is indicated for the insertion of foldable intraocular lenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge.

Source page: https://510kreport.com/device/K040837
Methodology: https://510kreport.com/methodology