# K983581: Ocu-Guard and Ocu-Guard Supple

- Pathway: 510(k) (Special)
- Applicant: Bio-Vascular, Inc.
- Decided: Nov 6, 1998 after 24 days
- Product code: HQX (Implant, Orbital, Extra-Ocular)
- Device class: 2
- Regulation: 21 CFR 886.3340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K842066 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973552: Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap, Bio-Vascular, Inc. (1997) Summary page 1.

## Indications for use
Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.

Source page: https://510kreport.com/device/K983581
Methodology: https://510kreport.com/methodology