# K990749: Sof-Suction Fluid Evacuation System

- Pathway: 510(k) (Traditional)
- Applicant: X-Tech Medical, LLC
- Decided: Apr 2, 1999 after 25 days
- Product code: HOZ (Sponge, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4790
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Merocel Sponge Points: named in the summary without a submission number
- (no number) Datex-Ohmeda Suction Tubing: named in the summary without a submission number

## Indications for use
The Sof-Suction™ Fluid Evacuation System is used to remove excess irrigation fluids from the medial canthus of the eye during microscopic eye surgery to mitigate the effects of disturbing reflections from the fluid surface and to prevent stagnant irrigating fluid from entering the eye

Source page: https://510kreport.com/device/K990749
Methodology: https://510kreport.com/methodology