# K211148: CORE-Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Incore Co., Ltd.
- Decided: Jun 21, 2022 after 428 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 K920110 (1992). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141594: Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar, Unimicro Medical Systems (Shenzhen) Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K240196: Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K211148
Methodology: https://510kreport.com/methodology