510(k) Report

FDA applicant

Specialities Remeex International, S.L.

Minneapolis, MN3 decisions2004–20060 recalls

FDA records 3 decisions for Specialities Remeex International, S.L. (Minneapolis, MN) from 2004 to 2006: 3 510(k) clearances. Most are in product codes OTM (Mesh, Surgical, For Stress Urinary…) and PAH (Mesh, Surgical, Synthetic, Urogynecologic, For…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is 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 Specialities Remeex International, S.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Specialities Remeex International, S.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Specialities Remeex International, S.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?

  • OTMMesh, Surgical, For Stress Urinary Incontinence, Male1decision
  • PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female…1decision
  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K033310Remeex System for Urinary IncontinenceSpecialities Remeex International, S.L. · 20043cite it

What has FDA decided for it lately?

  • K063136Needleless SlingSpecialities Remeex International, S.L. · 2006
  • K062341Male Remeex SystemSpecialities Remeex International, S.L. · 2006
  • K033310Remeex System for Urinary IncontinenceSpecialities Remeex International, S.L. · 2004

All 3 as Specialities Remeex International, S.L. →