MONOFIX PDO— 510(k) K253879
Substantially EquivalentSamyang Holdings Corporation
FDA 510(k) clearance K253879 for MONOFIX PDO, Substantially Equivalent on 2026-08-25. Applicant: Samyang Holdings Corporation. Device class: 2.
Clearance details
- Applicant
- Samyang Holdings Corporation
- Product code
- 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
- Traditional
- Location
- Daedeok-Gu, KR
Recent devices under product code NEW
view all- K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
- K252171 — Barbed PDO Suture
- K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
- K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO)
Adverse 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.