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510(k) K250107

V-soft Line™ Barbed Surgical Suture (Various) by Feeltech Co., Ltd. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2025
Date Received
January 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

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  • K172602 — Miracu (November 14, 2018)

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  • K252644 — PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PIN (September 23, 2025)
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