# K080158: LB Medical Inflatable Tissue Elevator/Expander System

- Pathway: 510(k) (Traditional)
- Applicant: Lb Medical LLC
- Decided: May 2, 2008 after 100 days
- Product code: FZW (Expander, Surgical, Skin Graft)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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 K981251 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 5.
- K061903: Relieva Sinus Balloon Catheter, Acclarent, Inc. (2006) Summary page 5.
- K972109: Spacemaker Surgicalballoon Dissector/Expander, General Surgical Innovations (1997) Summary page 5.
- K061937: Cook Endoscopy Esophageal Dilation Balloon, Cook Endoscopy (2006) Summary page 5.
- (no number) Preamendment: Elevator/Probe/Groove Director/Freer: named in the summary without a submission number

## Indications for use
The LB Medical Inflatable Tissue Elevator/Expander System is a surgical tool intended for use as a conventional manual elevator for orthopaedic or general surgery, including use to access the carpal tunnel region during carpal tunnel release procedures.

Source page: https://510kreport.com/device/K080158
Methodology: https://510kreport.com/methodology