# K142548: Midsleeve

- Pathway: 510(k) (Traditional)
- Applicant: Medical Innovation Development
- Decided: Jun 23, 2015 after 286 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: 3 generations back to K002838 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071764: Realize Gastric Calibration Tube, Models GCT180, GCT360, Obtech Medical Sarl (2007) Summary page 4.
- K130483: Boehringer Gastric Sizing Tube, Boehringer Laboratories, LLC (2013) Summary page 4.

## Indications for use
MIDSLEEVE, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.

Source page: https://510kreport.com/device/K142548
Methodology: https://510kreport.com/methodology