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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K263073
Device Name Fast Absorbing PGLA
Applicant
Riverpoint Medical, LLC
825 NE 25th Ave.
Portland,  OR  97232
Applicant Contact Rose Nakaweesi
Correspondent
Riverpoint Medical, LLC
825 NE 25th Ave.
Portland,  OR  97232
Correspondent Contact Rose Nakaweesi
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/01/2026
Decision Date 09/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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