K232042

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);

510(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);
Applicant
Mediconcepts Technology (Shenzhen) Company Limited CN
Product code
GCJ — Laparoscope, General & Plastic Surgery
Decision date
2023-10-20
Date received
2023-07-10
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K232042.pdf

Official FDA record: K232042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.