# K082102: Gastric Port, Models: Gap-0016-00, Gap-0018-00, Gap-0020-00

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Endosurgery, Inc.
- Decided: Jun 14, 2010 after 689 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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. The FDA summary names no predicate by number.

## Indications for use
The Gastric Port is intended to be used with an endoscope to facilitate intubation of the endoscope as a guide for various flexible endoscopic instruments for intraluminal procedures. The safety and effectiveness of this device for Natural Orifice Transluminal Endoscopic Surgery (NOTES) has not been demonstrated.

Source page: https://510kreport.com/device/K082102
Methodology: https://510kreport.com/methodology