# K980816: Retinal Detachment Implants, Including Bands, Strips (Rails) and Sponges

- Pathway: 510(k) (Traditional)
- Applicant: Fci Ophthalmics, Inc.
- Decided: Sep 18, 1998 after 199 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient’s vision

Source page: https://510kreport.com/device/K980816
Methodology: https://510kreport.com/methodology