# K080067: Iscience Interventional Ophthalmic Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Iscience Interventional
- Decided: Jul 18, 2008 after 190 days
- Product code: MPA (Endoilluminator)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K884043 (1988). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041108: Iscience Surgical Ophthalmic Microcannula, Iscience Surgical Corporation (2004) Summary page 1.
- K970882: Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.), American Medical Devices, Inc. (1997) Summary page 1.
- K973293: Syntec True Light End Irrigating Endoilluminator, Vaughan Weeks (1997) Summary page 1.

## Most influential descendants
- 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
- K253468: Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) (2026), 0 descendants of its own
- K253760: OMNI Ultra Surgical System (1-110) (2026), 0 descendants of its own

## Recalls of this device
- Jan 11, 2018 · Class II · Z-0011-2019: Sterility failure found in one of the units in the lot.
- Aug 6, 2014 · Class II · Z-2590-2014: One lot may not have been properly sealed, resulting in a non-sterile device.

## Indications for use
The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adulit patients with open angle glaucoma.

Source page: https://510kreport.com/device/K080067
Methodology: https://510kreport.com/methodology