# K220455: Lap-Band System Calibration Tube

- Pathway: 510(k) (Traditional)
- Applicant: Reshape Lifesciences
- Decided: Jun 7, 2022 after 110 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: 1 generation back to K002838 (2001). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002838: Gastric Suction and Drainage Catheter, Bioenterics Corp. (2001) Summary page 4.

## Most influential descendants
- K221898: Gastrointestinal Boundary Identifier (GIBI HD) (2022), 2 descendants of its own
- K250389: XNY Disposable Gastric Calibration Tube (2025), 0 descendants of its own
- K241039: ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (2024), 0 descendants of its own
- K230131: ReShape Calibration Tubes (2023), 0 descendants of its own

## Indications for use
The LAP-BAND® System Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.

Source page: https://510kreport.com/device/K220455
Methodology: https://510kreport.com/methodology