# P070009: Realize Adjustable Gastric Band Model 2200-X

- Pathway: PMA
- Applicant: Obtech Medical GmbH
- Decided: Sep 28, 2007 after 179 days
- Product code: LTI (Implant, Intragastric For Morbid Obesity)
- Device class: 3
- Recalls of this device: 19 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 30, 2013 · Class II · Z-0149-2014: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
- Sep 30, 2013 · Class II · Z-0150-2014: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
- Sep 30, 2013 · Class II · Z-0151-2014: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
- Sep 27, 2010 · Not classified · Z-0289-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0291-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0292-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0297-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0298-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0293-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0299-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0302-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0290-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0294-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0295-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0296-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0300-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0301-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0303-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie
- Sep 27, 2010 · Not classified · Z-0304-2011: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relie

Source page: https://510kreport.com/device/P070009
Methodology: https://510kreport.com/methodology