# K962104: Airlift Balloon Retracton System

- Pathway: 510(k) (Traditional)
- Applicant: Origin Medsystems, Inc.
- Decided: Sep 11, 1996 after 104 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942678 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942678: Lifting Distention Balloon System, Origin Medsystems, Inc. (1994) Summary page 2.

## Indications for use
The Airlift Jr™ Balloon Retraction System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used as an alternative to insufflation for retracting organs and tissues thus creating a working cavity for endoscopic surgery.

Source page: https://510kreport.com/device/K962104
Methodology: https://510kreport.com/methodology