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.
Summary
Samyang Holdings filed MONOFIX PDO under product code NEW, absorbable polydioxanone surgical sutures. The record gives no sizes or model numbers.
Class II, 21 CFR 878.4840. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Samyang filed from Daedeok-Gu, South Korea. The decision came 264 calendar days after receipt (December 4, 2025 to August 25, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Samyang Holdings Corporation
- 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
- Traditional
- Location
- Daedeok-Gu, KR
Recent devices under product code NEW
view all- K254238 — MINT MONO Sutures
- 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
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.