SURGIMESH XB— 510(k) K072974
Substantially EquivalentAspide Medical
FDA 510(k) clearance K072974 for SURGIMESH XB, Substantially Equivalent on 2008-08-18. Applicant: Aspide Medical. Device class: 2.
Clearance details
- Applicant
- Aspide Medical
- Product code
- Code FTL
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code FTL
view allMore clearances from Aspide Medical
view allAdverse events under product code FTL
product code FTL- Death
- 317
- Injury
- 66,072
- Malfunction
- 1,273
- Other
- 3
- Total
- 67,665
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 →
Recalls naming K072974
K-number listed on FDA's recall record- Z-1984-2025 — SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
- Z-1985-2025 — SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072974.
Data sourced from openFDA. This site is unofficial and independent of the FDA.