# K980636: Fiber Optic Endoillumination Probe

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic USA, Inc.
- Decided: May 20, 1998 after 90 days
- Product code: FFS (Image, Illumination, Fiberoptic, For Endoscope )
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K870942 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870942: MVS Fiberoptic Lightpipe, Advanced Surgical Products, Inc. (1987) Summary page 1.

## Indications for use
Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

Source page: https://510kreport.com/device/K980636
Methodology: https://510kreport.com/methodology