# K180826: Natrelle 133 Plus MICROCELL Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Allergan
- Decided: Dec 21, 2018 after 266 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
Longest line of descent: 3 generations back to K011500 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143354: Natrelle 133 Plus Tissue Expander, Allergan, Inc. (2015) Summary page 4.

## Indications for use
The Natrelle® 133 Plus MICROCELL™ Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Source page: https://510kreport.com/device/K180826
Methodology: https://510kreport.com/methodology