Skip to content

Core-Trocar

by Incore Co., Ltd.

510(k) K211148

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211148 Date21 Jun 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Core-Trocar is a Laparoscopic Trocar (Product Code: GCJ), designed as a disposable sterile device for creating an insertion pathway during minimally invasive abdominal surgeries. It combines a cannula to maintain instrument alignment and a trocar to facilitate the entry of laparoscopic tools, including the laparoscope itself. This device is intended for use in procedures requiring controlled access to the peritoneal cavity, such as diagnostic laparoscopy or surgical interventions. Its construction ensures a secure and atraumatic entry point while minimizing tissue trauma.

Supplied as a single-use, sterile device, the Core-Trocar is intended for use in sterile surgical settings, adhering to standard laparoscopic protocols. It is cleared for use in the United States under FDA 510(k) clearance (K211148), following review by the Gastroenterology and Urology Advisory Committees. The device is classified as a Class II General & Plastic Surgery product and is manufactured by Incore Co., Ltd. in Daegu, South Korea. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.

Other devices from Incore Co., Ltd.

See all devices from Incore Co., Ltd. →