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510(k) Data Aggregation
K Number
K221365Device Name
LapBox Tissue Containment Removal System
Manufacturer
ARK Surgical, Ltd.
Date Cleared
2022-08-25
(105 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ARK Surgical, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LapBox Tissue Containment Removal System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
Device Description
The LapBox Tissue Containment Removal System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be manually morcellated. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.
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