Spatz3 Adjustable Balloon System
Basic Information
- Primary DI
- 00860005178810
- Basic UDI-DI Code
- B-00860005178810
- Reference
- A-SP3-03K
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Spatz FGIA Inc.
Additional Description
The Spatz3 Adjustable Balloon Systemยฎ is designed to assist weight loss by partially filling the stomach and inducing satiety. The Spatz3 Adjustable Balloon Systemยฎ is placed in the stomach and filled with saline, causing it to expand into a spherical shape. The filled balloon is designed to act as a space filler and move freely within the stomach. The unique inflation tube design of the Spatz3 Adjustable Balloon Systemยฎ permits balloon volume adjustment at the time of placement, and at a later time. Balloon volume may range from 400 -700 ml. The Spatz3 Adjustable Balloon Systemยฎ consists of a balloon connected to a curved catheter containing an extendable Inflation tube that is connected to an extension tube. The extendable inflation tube exits the catheter behind the balloon, which enables balloon adjustment after the initial implantation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| G030601 | INTRAGASTRIC BALLOON SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 170222 QS/NB | INSTITUT PRO TESTOVรNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).