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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtools, Assisted Reproduction (Pipettes)
510(k) Number K261234
Device Name The D-Tip Denudation Pipette
Applicant
Allwin Medical Devices, Inc.
3305 E. Mira Loma Ave.
Suite 176
Anaheim,  CA  92806
Applicant Contact Digish Mehta
Correspondent
Allwin Medical Devices, Inc.
3305 E. Mira Loma Ave.
Suite 176
Anaheim,  CA  92806
Correspondent Contact Digish Mehta
Regulation Number884.6130
Classification Product Code
MQH  
Date Received04/15/2026
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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