# K221898: Gastrointestinal Boundary Identifier (GIBI HD)

- Pathway: 510(k) (Special)
- Applicant: Reshape Lifesciences
- Decided: Jul 28, 2022 after 28 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002838 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220455: Lap-Band System Calibration Tube, Reshape Lifesciences (2022) Summary page 4.

## Most influential descendants
- K250389: XNY Disposable Gastric Calibration Tube (2025), 0 descendants of its own
- K230131: ReShape Calibration Tubes (2023), 0 descendants of its own

## Indications for use
The GIBI HDTM is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

Source page: https://510kreport.com/device/K221898
Methodology: https://510kreport.com/methodology