Barbed PDO Suture— 510(k) K252171
Substantially EquivalentSutura Medical Technology, Inc.
FDA 510(k) clearance K252171 for Barbed PDO Suture, Substantially Equivalent on 2026-06-12. Applicant: Sutura Medical Technology, Inc.. Device class: 2.
Summary
Sutura Medical Technology's Barbed PDO Suture is filed under NEW, absorbable polydioxanone surgical sutures. The barbed design comes from the device name; the record gives no sizes.
Class II, 21 CFR 878.4840. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Sutura filed from Dedham, Massachusetts. The decision came 337 calendar days after FDA received it (July 10, 2025 to June 12, 2026).
Clearance details
- Applicant
- Sutura Medical Technology, Inc.
- 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
- Dedham, MA, US
Recent devices under product code NEW
view all- K254238 — MINT MONO Sutures
- K253879 — MONOFIX PDO
- K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical 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.