NexPort Trocar System (14 models)— 510(k) K232042
Substantially EquivalentMediconcepts Technology (Shenzhen) Company Limited
FDA 510(k) clearance K232042 for NexPort Trocar System (14 models), Substantially Equivalent on 2023-10-20. Applicant: Mediconcepts Technology (Shenzhen) Company Limited. Device class: 2.
Clearance details
- Device name as filed
- 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
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code GCJ
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- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.