# K973293: Syntec True Light End Irrigating Endoilluminator

- Pathway: 510(k) (Traditional)
- Applicant: Vaughan Weeks
- Decided: Nov 18, 1997 after 77 days
- Product code: MPA (Endoilluminator)
- 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 K884043 (1988). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884043: Grieshaber Micro Lite Light Pipe 19 & 20 Gauge, Grieshaber & Co. (1988) Summary page 1.

## Most influential descendants
- K041108: Iscience Surgical Ophthalmic Microcannula (2004), 10 descendants of its own
- K080067: Iscience Interventional Ophthalmic Microcatheter (2008), 9 descendants of its own
- K173332: OMNI Surgical System (2017), 6 descendants of its own
- K202678: OMNI Surgical System (2021), 2 descendants of its own
- K232214: OMNI Surgical System (2023), 1 descendant of its own

## Indications for use
The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible.specFrum.llght the intra ocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.

Source page: https://510kreport.com/device/K973293
Methodology: https://510kreport.com/methodology