# K210278: Titan SGS

- Pathway: 510(k) (Traditional)
- Applicant: Standard Bariatrics
- Decided: Apr 28, 2021 after 86 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K051002 (2005). 9 ancestors in all.
No later device cites it as a predicate yet.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140560: Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus Articulating, Ethicon Endo-Surgery, LLC (2014) Summary page 4.

## Indications for use
The Titan SGS linear cutter is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation.

Source page: https://510kreport.com/device/K210278
Methodology: https://510kreport.com/methodology