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510(k) Data Aggregation
K Number
K223562Device Name
Xpan Universal Trocar System
Manufacturer
Date Cleared
2023-06-02
(186 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Xpan Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Xpan Universal Trocar System is a single use system that is intended to provide dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. The system is indicated for the following uses:
- · Laparoscopic access to the abdominal cavity, both primary and secondary punctures.
- · Thoracoscopic access to the thoracic cavity, both primary and secondary punctures.
Device Description
The Xpan Universal Trocar System provides a universal port solution wherein the 3mm expandable port is radially expandable from 3mm up to 12mm. Xpan is offered in three sizes and is a single use device. The 5mm and 12mm cannulas are supplied with an optical bladeless tip and include a detachable valve to allow for specimen removal or rapid desufflation. The 3mm expandable trocar can be assembled with the 5mm or 12mm Xpan obturators after tissue insertion or before tissue insertion if desired. The exterior shaft of the 3mm expandable trocar is ribbed to provide security in tissue once inserted in tissue.
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