FDA-Device2016-12-28Class II
Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
Northgate Technologies, Inc.
Hazard
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Sold states
Worldwide Distribution - US including FL and MA. Internationally to Canada
Affected count
49 devices
Manufactured in
1591 Scottsdale Ct, N/A, Elgin, IL, United States
Products
Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0866-2017Don't want to check this manually?
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