# K090309: Lagis Endoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Lagis Enterprises Co, Ltd.
- Decided: Aug 28, 2009 after 203 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K924469 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951589: Manual Surgical Insrument, United States Surgical, A Division of Tyco Healthc (1995) Summary page 1.
- K924469: Graspers & Scissors (Minimal Access Surg Instr), Conmedcorp (1993) Summary page 1.

## Indications for use
The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.

Source page: https://510kreport.com/device/K090309
Methodology: https://510kreport.com/methodology