FDA-Device2020-10-28Class II
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
Bien-Air Surgery Sa
Hazard
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Sold states
US Nationwide distribution including in the states of CA, MI and MN.
Affected count
N/A
Manufactured in
rue de l' ouest 2b, N/A, Le Noirmont, N/A, Switzerland
Products
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0180-2021Don't want to check this manually?
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