Cleared Special

K261988 - Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture

K261988 is an FDA 510(k) clearance for Monodek (POLYDIOXANONE) Dyed Violet Mon..., manufactured by Teleflex Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Special 510(k) pathway after a 27-day FDA review.

K261988 · Teleflex Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
27d
Days
Class 2
Risk

K261988 is an FDA 510(k) clearance for the Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgic.... Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Teleflex Medical, LLC (Morrisville, US). The FDA issued a Cleared decision on July 9, 2026 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Teleflex Medical, LLC devices

FDA 510(k) Submission Details - K261988

510(k) Number K261988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2026
Decision Date July 09, 2026
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

NEW Device Classification - Class 2, Special Controls

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEW Suture, Surgical, Absorbable, Polydioxanone

All 54
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K261988.
MONOFIX PDO
K253879 · Samyang Holdings Corporation · Aug 2026
Barbed PDO Suture
K252171 · Sutura Medical Technology, Inc. · Jun 2026
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
K252047 · Ethicon, Inc. · May 2026
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
K243897 · Ethicon, Inc. · Nov 2025
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
K251414 · Feeltech Co., Ltd. · Oct 2025
V-soft Line™ Barbed Surgical Suture (Various)
K250107 · Feeltech Co., Ltd. · Oct 2025