OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device

Electrosurgical, Cutting & Coagulation & Accessories

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Optablate Rf Generator, Optablate Probes, Optablate Microinfuser Infusion Device.

Pre-market Notification Details

Device IDK221074
510k NumberK221074
Device Name:OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Stryker Corporation 1941 Stryker Way Portage,  MI  49002
ContactBruce Backlund
CorrespondentBruce Backlund
Stryker Corporation 1941 Stryker Way Portage,  MI  49002
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-12
Decision Date2022-09-16

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