# K934834: Eptfe Sheet Covering for Ocular Implant

- Pathway: 510(k) (Traditional)
- Applicant: Oculo Plastik, Inc.
- Decided: May 5, 1994 after 209 days
- Product code: HPZ (Implant, Eye Sphere)
- 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K070130: Orbital Reconstructive Implant (2007), 1 descendant of its own
- K973552: Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap (1997), 1 descendant of its own
- K083342: Orbital Reconstructive Implant II (2009), 0 descendants of its own
- K983581: Ocu-Guard and Ocu-Guard Supple (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K934834
Methodology: https://510kreport.com/methodology