# K946357: Collagen Intracanalicular Plug

- Pathway: 510(k) (Traditional)
- Applicant: Oasis Medical, Inc.
- Decided: Feb 7, 1995 after 39 days
- Product code: LZU (Plug, Punctum)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040912: Hydrogel Canalicular Plug (2004), 1 descendant of its own
- K013613: Soft Plug Absorbable Plug-SA (2002), 1 descendant of its own
- K222164: Visant Medical Canalicular Plug (2022), 0 descendants of its own
- K053333: Eaglevision Gellanserts, Model Ref 0040 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K946357
Methodology: https://510kreport.com/methodology