# K171939: ALVUE Balloon Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Mar 7, 2018 after 252 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: 4 generations back to K944418 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090631: Pajunk Disposable Balloons and Balloon Systems, PAJUNK GmbH Medizintechnologie (2009) Summary page 4.
- K973046: Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak, General Surgical Innovations (1998) Summary page 4.

## Indications for use
The ALVUE™ Balloon Dilation System is indicated for patients undergoing surgical procedures requiring tissue retraction including the following procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery; spine surgery; orthopedic surgery; thoracoscopic surgery; and procedures in the extraperitoneal space. The system is intended to create an operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal, subcutaneous extremity, or thoracic space.

Source page: https://510kreport.com/device/K171939
Methodology: https://510kreport.com/methodology