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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
510(k) Number K220420
Device Name Saffron Fixation System
Applicant
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact Gayatri Ghadge
Correspondent
Coloplast A/S
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact Gayatri Ghadge
Regulation Number884.4530
Classification Product Code
PBQ  
Date Received02/14/2022
Decision Date 06/10/2022
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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