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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K150969
Device Name Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Applicant Contact Jennifer Michelle Chambers
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave.
El Segundo,  CA  90245
Correspondent Contact Jennifer Michelle Chambers
Regulation Number874.4250
Classification Product Code
ERL  
Date Received04/13/2015
Decision Date 01/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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