# K041108: Iscience Surgical Ophthalmic Microcannula

- Pathway: 510(k) (Traditional)
- Applicant: Iscience Surgical Corporation
- Decided: Jun 22, 2004 after 55 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: 2 generations back to K884043 (1988). 4 ancestors in all.
10 later devices descend from it; 1 cites 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)
- 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.
- K010305: Weiss Retinal Cannula, Micron Surgical, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K253468: Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) (2026), 0 descendants of its own

## Indications for use
The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, with illumination, during surgery.

Source page: https://510kreport.com/device/K041108
Methodology: https://510kreport.com/methodology