# K240196: Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)

- Pathway: 510(k) (Traditional)
- Applicant: Yuwonmeditech Co., Ltd.
- Decided: Jun 18, 2024 after 145 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: 4 generations back to K920110 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211148: CORE-Trocar, Incore Co., Ltd. (2022) Summary page 5.

## Indications for use
ENPOLE is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.

Source page: https://510kreport.com/device/K240196
Methodology: https://510kreport.com/methodology