# K983385: Hutchison Inflatable Silicone Tissue Expanders

- Pathway: 510(k) (Traditional)
- Applicant: Hutchison Intl., Inc.
- Decided: Mar 15, 1999 after 171 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 no predicate by number.

## Indications for use
The HUTCHISON Inflatable Silicone Tissue Expanders are designed for temporary use in: Scar/defect revision Reconstruction of the breast following subcutaneous mastectomy and other suitable procedures or trauma Breast underdevelopment and combined breast and chest wall abnormalities

Source page: https://510kreport.com/device/K983385
Methodology: https://510kreport.com/methodology