FDA-Device2022-12-21Class II

Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187

ConMed Corporation
Hazard

Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.

Sold states
Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon.
Affected count
23,700 US; 5,225 OUS
Manufactured in
525 French Rd, N/A, Utica, NY, United States
Products
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0474-2023

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