DURAMESH Mesh Suture— 510(k) K211178
Substantially EquivalentMsi
FDA 510(k) clearance K211178 for DURAMESH Mesh Suture, Substantially Equivalent on 2022-09-02. Applicant: Msi. Device class: 2.
Clearance details
- Applicant
- Msi
- Product code
- Code GAW
- Device class
- Class 2
- Regulation
- 21 CFR 878.5010
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code GAW
view all- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- K233355 — Cypris eXact Suturing System
- K230746 — Non absorbable Surgical Polypropylene Suture
- K221280 — Vesseal
- K192953 — APTOS Threads Polypropylene Surgical Sutures
Adverse events under product code GAW
product code GAW- Death
- 66
- Injury
- 1,616
- Malfunction
- 10,428
- Total
- 12,110
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.