FDA-Device2022-11-30Class II

eSuction Small Cavity, Model ET2005

Endo-Therapeutics, Inc.
Hazard

Improper device regulatory classification

Sold states
US distribution to Florida and Pennsylvania
Affected count
28 devices
Manufactured in
15201 Roosevelt Blvd Ste 104, N/A, Clearwater, FL, United States
Products
eSuction Small Cavity, Model ET2005

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0270-2023

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