Scion Balloon Elevator
510(k) K973698
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973698 | Date31 Mar 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Scion Balloon Elevator is a surgical device classified under General & Plastic Surgery (Product Code GCJ). It is designed to assist in endoscopic procedures by providing atraumatic support and gentle tissue separation within extraperitoneal or subcutaneous spaces, such as during saphenous vein harvest.
This device is intended for single-use and is supplied sterile. It attaches to the distal end of the Scion Endoscope Retractor (510K #93006) to facilitate retraction and tissue manipulation. The balloon component expands to spread tissue gently, aiding visibility and access during minimally invasive procedures. Authorized under FDA 510(k) clearance (K973698), it adheres to regulatory standards for Class II devices.
Other devices from Scion International, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of surgical procedures is the Scion Balloon Elevator specifically designed to assist with, and how does it function during these procedures?
The Scion Balloon Elevator is designed to assist in endoscopic procedures where gentle tissue separation is needed, particularly during saphenous vein harvest or other extraperitoneal/subcutaneous surgeries. It attaches to the distal end of the Scion Endoscope Retractor to provide atraumatic support and improve visibility by inflating a balloon component. This inflation spreads tissue gently, creating space for better access and manipulation without damaging surrounding areas.
Is the Scion Balloon Elevator reusable, or is it intended for single-use only? How does this affect its sterility and handling?
The Scion Balloon Elevator is explicitly intended for single-use only, which means it is supplied sterile to ensure patient safety and prevent cross-contamination. Since it is not designed for reuse, proper handling and disposal after a single procedure are critical to maintain sterility and compliance with medical device regulations.
How is the Scion Balloon Elevator regulated, and what does its classification under Product Code GCJ (General & Plastic Surgery) imply about its intended use?
The Scion Balloon Elevator is classified under Product Code GCJ (General & Plastic Surgery) and has received FDA 510(k) clearance (K973698) under the Traditional review pathway. This classification indicates it is intended for surgical applications in general and plastic surgery contexts, specifically for use in minimally invasive procedures like tissue separation during endoscopic surgeries. The clearance confirms it meets regulatory standards for Class II devices.
Does the Scion Balloon Elevator require any specific attachment or compatibility with other devices, and how does this affect its functionality?
Yes, the Scion Balloon Elevator is designed to attach exclusively to the distal end of the Scion Endoscope Retractor (510K #93006). This compatibility ensures proper retraction and tissue manipulation during procedures, as the balloon component relies on the retractor’s mechanism to expand and create space. Using it with other devices could compromise its intended function and safety.