# K203586: EndoSerter-PL

- Pathway: 510(k) (Traditional)
- Applicant: Corneagen, Inc.
- Decided: Feb 2, 2022 after 421 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
Longest line of descent: 2 generations back to K090626 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121579: EK Delivery Device, Tdak Medical, Inc. (2012) Summary page 4.

## Indications for use
The EndoSerter®-PL is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.0 mm in diameter and 100 microns in central thickness into the anterior chamber through a minimum 4.0 mm incision during endothelial keratoplasty procedures and for loading and storage of donor tissue during transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 48 hours.

Source page: https://510kreport.com/device/K203586
Methodology: https://510kreport.com/methodology