510(k) Report

FDA applicant

Aspide Medical

Washington, DC4 decisions2007–20124 recalls

FDA records 4 decisions for Aspide Medical (Washington, DC) from 2007 to 2012: 4 510(k) clearances. All are in product code FTL (Mesh, Surgical, Polymeric). Its devices cite 16 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Aspide Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12008: 12010: 12012: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

4in 2022

2022: 4
2007high 4 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Aspide Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FTLMesh, Surgical, Polymeric4decisions

Whose devices does it build on?

Its devices cite 16 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061445Surgimesh WNAspide Medical · 20073cite it
  • K072974Surgimesh XBAspide Medical · 20082cite it

What has FDA decided for it lately?

  • K120025Surgimesh XB - SkirtedAspide Medical · 2012
  • K092233Surgimesh XDAspide Medical · 2010
  • K072974Surgimesh XBAspide Medical · 20082 recalls
  • K061445Surgimesh WNAspide Medical · 20072 recalls

All 4 as Aspide Medical →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K061445SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030Aug 12, 2022Class II
  • K061445SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415Aug 12, 2022Class II
  • K072974SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog…Aug 12, 2022Class II
  • K072974SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier…Aug 12, 2022Class II