FDA-Device2024-04-10Class II
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Karl Storz Endoscopy
Hazard
Inadequate reprocessing validation evidence
Sold states
US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
Affected count
27 units
Manufactured in
2151 E Grand Ave, El Segundo, CA, United States
Products
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1473-2024Don't want to check this manually?
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