FDA-Device2020-12-30Class II
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
GA HEALTH COMPANY LIMITED
Hazard
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Sold states
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Affected count
10,000
Manufactured in
Unit 18, 21/F, Metropole Square; 2 On Yiu Street ,Shatin, N.T, Shatin N.T., N/A, Hong Kong SAR
Products
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0642-2021Don't want to check this manually?
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