# K023643: Macropore Surgical Barrier Film

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Feb 21, 2003 after 114 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bio-Vascular Ocu-Guard: named in the summary without a submission number
- (no number) Bio-Eye II Orbital Implant: named in the summary without a submission number

## Indications for use
The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbital implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

Source page: https://510kreport.com/device/K023643
Methodology: https://510kreport.com/methodology