# K973552: Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Dec 16, 1997 after 88 days
- Product code: MTZ (Wrap, Implant, Orbital)
- Device class: 2
- Regulation: 21 CFR 886.3320
- 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 K842066 (1985). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934834: Eptfe Sheet Covering for Ocular Implant, Oculo Plastik, Inc. (1994) Summary page 1.
- K821532: Periguard Pericardial Patch, Genetic Laboratories, Inc. (1982) Summary page 1.
- K833021: Peri-Guard Pericardial Patch-Hernia, Genetic (1983) Summary page 1.
- K842066: Peri-Guard Pericardial Patch, Genetic Laboratories, Inc. (1985) Summary page 1.
- K961811: Peri-Guard Pericardium, Bio-Vascular, Inc. (1996) Summary page 1.
- K921895: Tissue Patch, Tissue Graft, Bio-Vascular, Inc. (1992) Summary page 1.
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 1.
- K961810: Supple Peri-Guard Pericardium, Bio-Vascular, Inc. (1996) Summary page 1.

## Most influential descendants
- K983581: Ocu-Guard and Ocu-Guard Supple (1998), 0 descendants of its own

## Indications for use
Ocu-Guard™ and Supple Ocu-Guard™ are 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 and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to faciiitate motility of the implant.

Source page: https://510kreport.com/device/K973552
Methodology: https://510kreport.com/methodology