K261988
- 510(k) number
- K261988
- Device name
- Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
- Applicant
- Teleflex Medical, LLC NC · US
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2026-07-09
- Date received
- 2026-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261988.pdf
Official FDA record: K261988
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.