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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labware, Assisted Reproduction
510(k) Number K262090
Device Name Fertilis microICSI Device
Applicant
Fertilis Pty, Ltd.
S310 / 1 Frome Rd., Helen Mayo S. Bldg.
The University Of Adelaide
Adelaide,  AU 5005
Applicant Contact Roger Yerramsetti
Correspondent
Fertilis Pty, Ltd.
S310 / 1 Frome Rd., Helen Mayo S. Bldg.
The University Of Adelaide
Adelaide,  AU 5005
Correspondent Contact Roger Yerramsetti
Regulation Number884.6160
Classification Product Code
MQK  
Date Received06/22/2026
Decision Date 10/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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