V-soft Line Barbed Surgical Suture (Various)— 510(k) K250107

Name: FDA 510(k) clearance K250107
Creator: U.S. Food and Drug Administration
Published: 2025-10-15

Substantially Equivalent

Feeltech Co., Ltd.

FDA 510(k) clearance K250107 for V-soft Line Barbed Surgical Suture (Various), Substantially Equivalent on 2025-10-15. Applicant: Feeltech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Feeltech Co., Ltd.
Product code: Product code NEW
Device class: Class 2
Regulation: 21 CFR 878.4840
Advisory panel: General, Plastic Surgery
Date received: 2025-01-15
Decision date: 2025-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunsan-Si, KR

Download summary PDF View on FDA.gov ↗

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K254238 — MINT MONO Sutures2026-09-18
K253879 — MONOFIX PDO2026-08-25
K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture2026-07-09
K252171 — Barbed PDO Suture2026-06-12
K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18

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K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO)2025-10-20
K213010 — FEELject LDV (Low dead volume) syringe2023-05-31
K172602 — Miracu2018-11-14

Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.