FDA-Device2018-04-04Class II
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Covidien LLC
Hazard
Product reportedly shutting down during use.
Sold states
Worldwide Distribution: US (Nationwide).
Affected count
2121
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2018Don't want to check this manually?
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