# K973698: Scion Balloon Elevator

- Pathway: 510(k) (Traditional)
- Applicant: Scion International, Inc.
- Decided: Mar 31, 1998 after 186 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Scion Balloon Elevator is designed for endoscoopic surgery involved in extraperitoneal or subcutaneous spaces in such common procedures as Saphenous Vein Harvest. The Balloon elevator is designed to fit on the end of our Endoscope Retractor (510K #9@006) and atraumatically provide support for the distal end of the retractor. The other function of the batioon is to gently spread tissue by the inflation of the balloon.

Source page: https://510kreport.com/device/K973698
Methodology: https://510kreport.com/methodology