# K013613: Soft Plug Absorbable Plug-SA

- Pathway: 510(k) (Traditional)
- Applicant: Oasis Medical, Inc.
- Decided: Jun 27, 2002 after 234 days
- Product code: LZU (Plug, Punctum)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890919 (1989). 4 ancestors in all.
1 later device descends 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)
- K946357: Collagen Intracanalicular Plug, Oasis Medical, Inc. (1995) Summary page 1.
- K890919: Temporary Intracanalicular Collagen Implant, Eagle Vision, Inc. (1989) Summary page 1.
- K895342: Collagen Implants for the Lacrimal Efficiency Test, Lacrimedics, Inc. (1989) Summary page 1.
- K896175: Herrick Lacrimal Plug TM., Lacrimedics, Inc. (1990) Summary page 1.

## Most influential descendants
- K053333: Eaglevision Gellanserts, Model Ref 0040 (2006), 0 descendants of its own

## Recalls of this device
- Jul 6, 2006 · Not classified · Z-1520-06: Labeled with an incorrect diameter

## Indications for use
The OASIS Medical Soft Plug@ Absorbable Plug - SA is intended for temporary use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blockage of tbe canaliculus. It may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, the OASIS Medical Soft Plug@ Absorbable Plug - SA may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye.

Source page: https://510kreport.com/device/K013613
Methodology: https://510kreport.com/methodology