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510(k) Data Aggregation
K Number
DEN170075Device Name
ContainOR
Manufacturer
Advanced Surgical Concepts Ltd.
Date Cleared
2017-12-19
(81 days)
Product Code
PZQ
Regulation Number
878.4825Why did this record match?
Applicant Name (Manufacturer) :
Advanced Surgical Concepts Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ContainOR is a bag containment system intended for use by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. The ContainOR is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
Device Description
The ContainOR device consists of two main components:
- A laparoscopic multi-instrument port .
- Tissue pouch (Bag) intended to provide a contained space in the abdomen for the safe morcellation of tissue.
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K Number
DEN150028Device Name
PneumoLiner
Manufacturer
ADVANCED SURGICAL CONCEPTS LTD.
Date Cleared
2016-04-07
(293 days)
Product Code
PMU
Regulation Number
884.4050Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED SURGICAL CONCEPTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
Device Description
The PneumoLiner System consists of two main components:
- A laparoscopic multi-instrument port
- Tissue pouch (PneumoLiner) intended to provide a separately contained space within the abdomen for the safe morcellation of tissue
As depicted in Figure 1 below, the laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer and the Boot Assembly.
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