Singapore HSA registration DE0017416
ConMed AirSeal® Optical Trocar & Cannula System with integrated Insufflator AirSeal® i.F.S.
Singapore·CLASS B·ConMed Corporation·Registered August 17, 2015Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0017416
- Registration Date
- August 17, 2015
- Change Notification Approval Date
- September 26, 2023
- Retention Due Date
- August 16, 2025
Product description
Intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric (≥ 20 kg) procedures where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis, and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.
Product Owner
- Short Name
- ConMed Corporation
- Address
- 525 French Road, Utica, New York 13502, UNITED STATES
Registrant
- Address
- 5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
- Address
- 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model information
- Model Name(s)
- iFS Cart 6" Bottle with Valve iFS Cart with Valve iFS Cart with Valve and two Bottle Racks AIRSEAL i.F.S. Intelligent Flow System - (120V) AIRSEAL i.F.S. Intelligent Flow System - (230V) AirSeal® Tri-Lumen Filtered Tube Set with Activated Charcoal Filter AirSeal® Bifurcated Filtered Tube Set with Activated Charcoal Filter AIRSEAL Bifurcated Smoke Evac Filtered Tube Set AIRSEAL Single Lumen Filtered Tube Set AirSeal® 12 mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100 mm Length AirSeal® 12 mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 120 mm Length AirSeal® 12 mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150 mm Length AIRSEAL 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length AIRSEAL 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length AirSeal® 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length AIRSEAL 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length AIRSEAL 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length AirSeal 8mm Cannula Cap and Obturator with Bladeless Optical Tip (Compatible with Intuitive da Vinci Xi and da Vinci X 8mm Instrument Cannula, Standard Length) AIRSEAL 12mm Access Port and Obturator with Blunt Tip, 100mm Length AIRSEAL 12mm Access Port and Obturator with Blunt Tip, 120mm Length AIRSEAL 5mm Access Port and Obturator with Blunt Tip, 150mm Length
- Model Identifier(s)
- AS-iCART-6V AS-iCART-V AS-iCART-V2R AS-iFS1 AS-iFS2 ASM-EVAC1 ASM-EVAC1-Bi SEM-EVAC SIM-TUB iAS12-100LPi iAS12-120LPi iAS12-150LPi iAS5-100LP iAS5-120LP iAS5-75LP iAS8-100LP iAS8-120LP iAS8-dV iASB12-100 iASB12-120 iASB5-150
About this record
Access comprehensive regulatory information for ConMed AirSeal® Optical Trocar & Cannula System with integrated Insufflator AirSeal® i.F.S. in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017416 and owned by ConMed Corporation. The device was registered on August 17, 2015.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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