510(k) Report

FDA applicant

Cousin Biotech Sas

Wervicq-Sud, FR8 decisions2000–20190 recalls

FDA records 8 decisions for Cousin Biotech Sas (Wervicq-Sud, FR) from 2000 to 2019: 8 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and OWI (Bone Fixation Cerclage, Sublaminar). Since 2016 its 510(k)s took a median of 259 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cousin Biotech S.A.R.L”, “Cousin Biotech”.

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 Cousin Biotech Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 12008: 12010: 12014: 12018: 22019: 1
2007high 2 (2018) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cousin Biotech Sas’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?

  • FTLMesh, Surgical, Polymeric5decisions
  • OWIBone Fixation Cerclage, Sublaminar2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 259 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 156 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K072962Cabs'airCousin Biotech Sas · 20083cite it
  • K172206NAJA™ Ligament Correction SystemCousin Biotech Sas · 20182cite it

What has FDA decided for it lately?

  • K181086Cortical Fixation SystemsCousin Biotech Sas · 2019
  • K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas · 2018
  • K172206NAJA™ Ligament Correction SystemCousin Biotech Sas · 2018
  • K133889PremiumCousin Biotech Sas · 2014
  • K093196Biomesh CA.B.S. 'Air Composite, Models: CABST1R05T, CABSAIRC7, CABSAIRC09Cousin Biotech Sas · 2010
  • K072962Cabs'airCousin Biotech Sas · 2008
  • K0709184DDOMECousin Biotech · 2007
  • K002479Biomesh P1 and Biomesh Plug and PatchCousin Biotech S.A.R.L · 2000

All 6 as Cousin Biotech Sas →The one decision as Cousin Biotech S.A.R.L →The one decision as Cousin Biotech →