510(k) Report

FDA applicant

Mpathy Medical Devices, Ltd.

Glasgow, GB7 decisions2004–20091 recall

FDA records 7 decisions for Mpathy Medical Devices, Ltd. (Glasgow, GB) from 2004 to 2009: 7 510(k) clearances. Most are in product codes OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…) and PAH (Mesh, Surgical, Synthetic, Urogynecologic, For…). Its devices cite 31 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Mpathy Medical Devices, Inc.”.

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 Mpathy Medical Devices, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2009

2008: 22009: 3
2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mpathy Medical Devices, Ltd.’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?

  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…2decisions
  • PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female…2decisions
  • OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse…2decisions
  • OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally…1decision

Whose devices does it build on?

Its devices cite 31 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 6 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.

  • K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 20046cite it
  • K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 20094cite it
  • K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 20063cite it
  • K091180Minitape Urethral SlingMpathy Medical Devices, Ltd. · 20091cites it
  • K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd. · 20081cites it
  • K073646Minitape Urethral SlingMpathy Medical Devices, Ltd. · 20081cites it

What has FDA decided for it lately?

  • K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
  • K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
  • K091180Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
  • K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd. · 2008
  • K073646Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2008
  • K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 20061 recall
  • K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 20041 recall

All 6 as Mpathy Medical Devices, Ltd. →The one decision as Mpathy Medical Devices, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041632Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460…Mar 2, 2012