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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K252644
Device Name PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
Applicant
M/s. Meril Endo Surgery Private Limited.
Third Floor, E1-E3, Meril Park, Survey # 135/2/B & 174/2
Vapi,  IN 396191
Applicant Contact Umesh Sharma
Correspondent
M/s. Meril Endo Surgery Private Limited.
Third Floor, E1-E3, Meril Park, Survey # 135/2/B & 174/2
Vapi,  IN 396191
Correspondent Contact Umesh Sharma
Regulation Number878.4840
Classification Product Code
NEW  
Subsequent Product Code
GAM  
Date Received08/21/2025
Decision Date 09/23/2025
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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