# K090626: Endoserter

- Pathway: 510(k) (Traditional)
- Applicant: Ocular Systems, Inc.
- Decided: Jan 21, 2011 after 683 days
- Product code: OTZ (Graft Insertion Instrument For Endothelial Keratoplasty)
- 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121579: EK Delivery Device (2012), 1 descendant of its own
- K203586: EndoSerter-PL (2022), 0 descendants of its own
- K102999: Trimotion Injector (2011), 0 descendants of its own

## Indications for use
The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures.

Source page: https://510kreport.com/device/K090626
Methodology: https://510kreport.com/methodology