510(k) Report

FDA applicant

Herniamesh S.R.L.

Jericho, NY4 decisions1998–20080 recalls

FDA records 4 decisions for Herniamesh S.R.L. (Jericho, NY) from 1998 to 2008: 4 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Herniamesh”.

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 Herniamesh S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Herniamesh S.R.L.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FTLMesh, Surgical, Polymeric2decisions
  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…1decision
  • PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female…1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K050516T-SlingHerniamesh S.R.L. · 20062cite it
  • K020652Herniamesh T-SlingHerniamesh · 20022cite it
  • K973955Herniamesh Surgical MeshesHerniamesh · 19981cites it

What has FDA decided for it lately?

  • K081327RelimeshHerniamesh S.R.L. · 2008
  • K050516T-SlingHerniamesh S.R.L. · 2006
  • K020652Herniamesh T-SlingHerniamesh · 2002
  • K973955Herniamesh Surgical MeshesHerniamesh · 1998

All 2 as Herniamesh S.R.L. →All 2 as Herniamesh →