510(k) Report

FDA applicant

Novus Scientific AB

Uppsala, SE3 decisions2010–20201 recall

FDA records 3 decisions for Novus Scientific AB (Uppsala, SE) from 2010 to 2020: 3 510(k) clearances. Most are in product codes OWT (Mesh, Surgical, Absorbable, Abdominal Hernia) and FTL (Mesh, Surgical, Polymeric). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Novus Scientific Pte, Ltd.”.

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 Novus Scientific AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010: 12017: 12020: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2010high 1 (2016) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Novus Scientific AB by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • OWTMesh, Surgical, Absorbable, Abdominal Hernia2decisions
  • FTLMesh, Surgical, Polymeric1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K092224Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd. · 20102cite it
  • K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB · 20201cites it
  • K163005TIGR Matrix Surgical MeshNovus Scientific AB · 20171cites it

What has FDA decided for it lately?

  • K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB · 2020
  • K163005TIGR Matrix Surgical MeshNovus Scientific AB · 2017
  • K092224Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd. · 20101 recall

All 2 as Novus Scientific AB →The one decision as Novus Scientific Pte, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K092224TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030Jul 19, 2016Class II

Other applicant names beginning “Novus”

FDA records each applicant name separately; these may or may not be the same firm.

Novus Monitoring, Ltd. 2Novus Technologies, Inc. 1