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NexPort™ Trocar System - NexPort™ Trocar System (TS211001)

by Mediconcepts Technology (Shenzhen) Company Limited

510(k) K232042

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232042 Date20 Oct 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
Models / Variants
NexPort™ Trocar System (TS211001)
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 NexPort Trocar System is a medical device used in gastroenterology and urology. It consists of multiple models, including TS211001, TS211002, TS211003, TS211010, TS211011, TS211012, TS221001, TS221002, TS221003, TS221010, TS221011, TS221012, TS221020, and TS221021. The device is designed to facilitate various medical procedures. It is a trocar system, which is typically used to insert instruments into the body during surgery. The NexPort Trocar System is used to provide access to the body cavity during surgical procedures.

The NexPort Trocar System is supplied in various models and sizes. It is a single-use device and is intended for use in a hospital setting. The device is made by Mediconcepts Technology (Shenzhen) Company Limited and has received FDA 510K authorization. The system is used in procedures related to gastroenterology and urology, and is classified under the product code GCJ. The device should be stored according to the manufacturer's instructions and used in accordance with the provided specifications.

Questions

AI-generated answers, 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.

  • What is the NexPort Trocar System used for?

    The NexPort Trocar System is used to provide access to the body cavity during surgical procedures in gastroenterology and urology.

  • Is the NexPort Trocar System reusable?

    No, the NexPort Trocar System is a single-use device, intended for use in a hospital setting and should be discarded after each use.

  • How should the NexPort Trocar System be stored?

    The device should be stored according to the manufacturer's instructions to maintain its integrity and ensure safe use.

  • What are the different models of the NexPort Trocar System?

    The NexPort Trocar System is available in multiple models, including TS211001, TS211002, TS211003, TS211010, TS211011, TS211012, TS221001, TS221002, TS221003, TS221010, TS221011, TS221012, TS221020, and TS221021.