Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)

Electrosurgical, Cutting & Coagulation & Accessories

Stryker Sustainability Solutions

The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Remanufactured Ligasure Exact Dissector, Without Nano-coating (lf2019).

Pre-market Notification Details

Device IDK220481
510k NumberK220481
Device Name:Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Stryker Sustainability Solutions 1810 W Drake Drive Tempe,  AZ  85283
ContactScott English
CorrespondentScott English
Stryker Sustainability Solutions 1810 W Drake Drive Tempe,  AZ  85283
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-18
Decision Date2022-05-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
57613327565312 K220481 000

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