# K240334: LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D,  DI-5731-33D, DI-5731-45D,  DI-5901-33D, DI-5901-45D)

- Pathway: 510(k) (Traditional)
- Applicant: Lagis Enterprise Co., Ltd.
- Decided: Oct 30, 2024 after 268 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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
Longest line of descent: 3 generations back to K910831 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012625: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, Alliance Medical Corp. (2001) Summary page 5.

## Indications for use
The LAGIS Endoscopic Instruments-Grasper has applications in a variety of minimally invasive procedures to facilitate grasping and mobilization of tissue.

Source page: https://510kreport.com/device/K240334
Methodology: https://510kreport.com/methodology