FDA.reportPublic FDA data

ADVANCED SURGICAL CONCEPTS (ASC)

Matched from indexed company URL: Advanced Surgical Concepts

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96167203003283598ADVANCED SURGICAL CONCEPTS (ASC)1N2020-04-25UNIT 4, SUNNYBANK CENTRE BRAY Wicklow IE --

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05391530440004PneumoLiner - 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. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner 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.The ASC PneumoLiner Device has two main components. It consists of:1. The PneumoLiner, a tissue pouch intended to provide a space within the abdomen for the safe morcellation of tissue; and2. A laparoscopic multi-instrument port.1. Multi-instrument PortThe laparoscopic multi-instrument port is comprised of the following three sub-components:The Retractor Introducer which delivers the Distal Ring of the Retractor through a premade incision, into the abdominal cavity.The Retractor which retracts an abdominal incision to allow the passage of laparoscopic instruments and provides an anchor for the Valve Component.The Boot Assembly which maintains the pneumoperitoneum established for the surgical procedure.2. PneumoLinerThe PneumoLiner, has two sub-components:An Introducer for delivery of the PneumoLiner.The PneumoLiner, that when under pneumoperitoneum provides a space for morcellation of the chosen tissue that can be visualized.+35312864777info@advancedsurgical.ie
05391530440011PneumoLiner - The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparosco+35312864777info@advancedsurgical.ie

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
568071238612996K121309ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEOTJ2012-09-06
568071374106102K111407TRIPORT, TRIPORT+, TRIPORT15, QUADPORTOTJ2012-01-18
568071406834034K110004ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEOTJ2011-01-26
568071107183725K101794ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WAOTJ2010-11-29
568071157371450K073719ASC TRIPORT LAPAROSCOPIC ACCESS DEVICEGCJ2008-01-29
568071377263313DEN150028PneumoLinerPMU2016-04-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OTJ42012-09-06
PMU12016-04-07
GCJ12008-01-29

PMN#

RedEx

2021-09-17

Advanced Surgical Concepts Ltd

OMNIPORT

2000-09-29

ADVANCED SURGICAL CONCEPTS (ASC)

GUDID#

PneumoLiner - 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. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner 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.The ASC PneumoLiner Device has two main components. It consists of:1. The PneumoLiner, a tissue pouch intended to provide a space within the abdomen for the safe morcellation of tissue; and2. A laparoscopic multi-instrument port.1. Multi-instrument PortThe laparoscopic multi-instrument port is comprised of the following three sub-components:The Retractor Introducer which delivers the Distal Ring of the Retractor through a premade incision, into the abdominal cavity.The Retractor which retracts an abdominal incision to allow the passage of laparoscopic instruments and provides an anchor for the Valve Component.The Boot Assembly which maintains the pneumoperitoneum established for the surgical procedure.2. PneumoLinerThe PneumoLiner, has two sub-components:An Introducer for delivery of the PneumoLiner.The PneumoLiner, that when under pneumoperitoneum provides a space for morcellation of the chosen tissue that can be visualized.

ADVANCED SURGICAL CONCEPTS LIMITED

2016-09-19

Guardenia - The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation. A system for the containment of tissue for reduction, with a scalpel (or similar instrument), and extraction. The device will retract the incision & contain the tissue being extracted. The device will provide protection of the containment component from inadvertent damage from sharp instruments used in the reduction process.

ADVANCED SURGICAL CONCEPTS LIMITED

2021-12-09

Guardenia - The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.A system for the containment of tissue for reduction, with a scalpel (or similar instrument), and extraction.The device will retract the incision & contain the tissue being extracted. The device will provide protection of the containment component from inadvertent damage from sharp instruments used in the reduction process.

ADVANCED SURGICAL CONCEPTS LIMITED

2021-12-09

TriPort15 - This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery.The ASC TriPort15 is a sterile, disposable endoscopic multi-instrument port. The device consists of the following:• An Introducer that allows the insertion of the Base Retractor into the abdomen through an incision.• A Base Retractor that retracts in an abdominal incision to allow laparoscopic instruments pass through to the abdomen. • A Boot contains three instrument valves and two ports that allow insufflation of the abdomen or venting of electrocautery gases. The Boot maintains pneumoperitoneum when attached and allows specimen removal when detached.

ADVANCED SURGICAL CONCEPTS LIMITED

2016-09-13

QuadPort+ - This device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.The ASC QuadPort+ is a sterile, disposable endoscopic multi-instrument port. The device consists of the following:• An Introducer that allows the insertion of the Base Retractor into the abdomen through an incision.• A Base Retractor that retracts in an abdominal incision to allow laparoscopic instruments pass through to the abdomen. • A Boot contains five instrument valves and two ports that allow insufflation of the abdomen or venting of electrocautery gases. The Boot maintains pneumoperitoneum when attached and allows specimen removal when detached.

ADVANCED SURGICAL CONCEPTS LIMITED

2016-09-13

TriPort+ - This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery.The ASC TriPort+ is a sterile, disposable endoscopic multi-instrument port. The device consists of the following:• An Introducer that allows the insertion of the Base Retractor into the abdomen through an incision.• A Base Retractor that retracts in an abdominal incision to allow laparoscopic instruments pass through to the abdomen. • A Boot contains four instrument valves and two ports that allow insufflation of the abdomen or venting of electrocautery gases. The Boot maintains pneumoperitoneum when attached and allows specimen removal when detached.

ADVANCED SURGICAL CONCEPTS LIMITED

2016-09-13