Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture— 510(k) K261988

Name: FDA 510(k) clearance K261988
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Substantially Equivalent

Teleflex Medical, LLC

FDA 510(k) clearance K261988 for Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture, Substantially Equivalent on 2026-07-09. Applicant: Teleflex Medical, LLC. Device class: 2.

Clearance details

Applicant: Teleflex Medical, LLC
Product code: Code NEW
Device class: Class 2
Regulation: 21 CFR 878.4840
Advisory panel: General, Plastic Surgery
Date received: 2026-06-12
Decision date: 2026-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18
K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture2025-11-12
K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO)2025-10-20

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K260775 — Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape2026-05-06

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.