Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
Device Facts
| Record ID | K261988 |
|---|---|
| Device Name | Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture |
| Applicant | Teleflex Medical, LLC |
| Product Code | NEW · General, Plastic Surgery |
| Decision Date | Jul 9, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4840 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.
Special Controls
*Classification.* Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
