UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

Karl Storz Endoscopy-America, Inc.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Unidrive S Ii Ent, Drillcut-x Ii-35 Shaver Handpiece, Drillcut-x Ii-35 N Shaver Handpiece.

Pre-market Notification Details

Device IDK200318
510k NumberK200318
Device Name:UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo,  CA  90245
ContactAlita Mcelroy
CorrespondentAlita Mcelroy
Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo,  CA  90245
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-07
Decision Date2020-10-22

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