# K030353: Monocanalicular Stents, Lacrimal Intubation Sets

- Pathway: 510(k) (Traditional)
- Applicant: Eagle Vision, Inc.
- Decided: Apr 25, 2003 after 81 days
- Product code: OKS (Lacrimal Stents And Intubation Sets)
- Device class: U
- 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 K883233 (1988). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883233: EV Monocanalicular Stent (TM), Eagle Vision, Inc. (1988) Summary page 1.
- K990672: Lacrimal Intubation Set, Dacryocystorhinostomy (DCR) Set, Hurricane Medical (1999) Summary page 1.
- K955671: Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.), G.W.B. Intl., Ltd. (1996) Summary page 1.

## Most influential descendants
- K113316: DCS Lacrimal Stent (2012), 1 descendant of its own
- K140290: Stoploss Jones Tube (2014), 0 descendants of its own

## Indications for use
The MonoStentTMMonocanalicular Stent, the EagleVisionB Lacrimal Intubation Set, and the EagleVisionB K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional OT laser); or imperforation of the nasolacrimal duct in an infant.

Source page: https://510kreport.com/device/K030353
Methodology: https://510kreport.com/methodology