# K053622: Surgisis Ocular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Iop, Inc.
- Decided: Mar 15, 2006 after 77 days
- Product code: NXM (Prosthesis, Eyelid Spacer/Graft, Biologic)
- Device class: 2
- Regulation: 21 CFR 886.3130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921895 (1992). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 2.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 2.
- K050246: Sis Dermal Augmentation Strand, Cook Biotech, Inc. (2005) Summary page 2.
- K032104: Amniolens, Bio-Tissue, Inc. (2003)

## Most influential descendants
- K090078: Kerasys Bioengineered Lamellar Patch Graft (2009), 1 descendant of its own
- K223074: CorNeat EverPatch (2023), 0 descendants of its own

## Indications for use
The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.

Source page: https://510kreport.com/device/K053622
Methodology: https://510kreport.com/methodology