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510(k) Data Aggregation

K Number

K232042

Device Name

NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021);

Manufacturer

MediConcepts Technology (Shenzhen) Company Limited

Date Cleared

2023-10-20

(102 days)

Product Code

GCJ

Regulation Number

876.1500

Intended Use

This device is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or minimally invasive procedures to establish a path of entry for minimally invasive instruments.

Device Description

The NexPort™ Trocar System is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed devices are available to accommodate 5mm and 10mm surgical instruments. The 5mm NexPort™ Trocar System is consisted of: - Obturator Shaft a) - Cannula Cap b) - Seal c) - Duckbill Valve d) - e) Cannula Body - f) Luerlock Cap - g) Obturator Tip Protector - Cannula Tip Protector h) The 10mm NexPort™ Trocar System is consisted of: - a) Obturator Shaft - Cannula Cap b) - Seal c) - Cannula Intermediate Plate d) - Duckbill Valve e) - f) Cannula Housing - Stopcock g) - Face Seal h) - i) Cannula Sleeve - Reducer j) - Adaptor Cap k) - I) Adaptor Top Body - m) Adaptor Seal - n) Adaptor Bottom Body

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