# K862203: Mcghan Magna-Site (TM) Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Mcghan Medical Corp.
- Decided: Jul 23, 1986 after 43 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: 4 (3 Class I)
- 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; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K102806: Natrelle 133 Tissue Expander with Suture Tabs (2011), 1 descendant of its own
- K972109: Spacemaker Surgicalballoon Dissector/Expander (1997), 1 descendant of its own
- K112534: Lifecell Tissue Expander (2012), 0 descendants of its own
- K080158: LB Medical Inflatable Tissue Elevator/Expander System (2008), 0 descendants of its own

## Recalls of this device
- Jul 24, 2019 · Class I · Z-2455-2019: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in pat
- Jul 24, 2019 · Class I · Z-2457-2019: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in pat
- Jul 24, 2019 · Class I · Z-2458-2019: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in pat
- Jun 18, 2015 · Class II · Z-2103-2015: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.

Source page: https://510kreport.com/device/K862203
Methodology: https://510kreport.com/methodology