SURGIMESH WN— 510(k) K061445
Substantially EquivalentAspide Medical
FDA 510(k) clearance K061445 for SURGIMESH WN, Substantially Equivalent on 2007-02-01. 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 K061445
K-number listed on FDA's recall record- Z-1983-2025 — SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
- Z-1986-2025 — SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061445.
Data sourced from openFDA. This site is unofficial and independent of the FDA.