# K983792: Seare Biomedical Silicone Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Seare Biomedical Corp.
- Decided: Dec 11, 1998 after 45 days
- Product code: LCJ (Tissue Expander And Accessories)
- 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.
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) Silicone Tissue Expanders manufactured and marketed by Specialty Surgical Products, Inc.: named in the summary without a submission number
- (no number) Silicone Tissue Expanders manufactured and marketed by McGhan Medical Corporation: named in the summary without a submission number

## Indications for use
Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

Source page: https://510kreport.com/device/K983792
Methodology: https://510kreport.com/methodology