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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K191281
Device Name Omni Hysteroscope, Omni Lok cervical seal
Applicant
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Applicant Contact Rachelle D. Fitzgerald
Correspondent
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Correspondent Contact Rachelle D. Fitzgerald
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
QHZ  
Date Received05/13/2019
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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