Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture— 510(k) K261988
Substantially EquivalentTeleflex 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.
Summary
Teleflex Medical's Monodek (polydioxanone) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture is filed under NEW, absorbable polydioxanone surgical sutures. The record doesn't give suture sizes or needle options.
Class II, 21 CFR 878.4840. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Special 510(k).
Teleflex filed from Morrisville, North Carolina. The decision came 27 calendar days after FDA received it (June 12 to July 9, 2026).
Clearance details
- Applicant
- Teleflex Medical, LLC
- Product code
- Product code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Morrisville, NC, US
Recent devices under product code NEW
view allMore clearances from Teleflex Medical, LLC
view allAdverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
Source: openFDA MAUDE database, through . 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.