510(k) Report

FDA applicant

Mesynthes, Ltd.

North Attleboro, MA2 decisions2010–20103 recalls

FDA records 2 decisions for Mesynthes, Ltd. (North Attleboro, MA) in 2010: 2 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 7 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Mesynthes, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

3in 2018

2018: 3
2010high 3 (2018) · low 0 (2010)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)2decisions

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 6 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.

  • K092096Endoform Dermal TemplateMesynthes, Ltd. · 20106cite it

What has FDA decided for it lately?

  • K101546Endoform Dental TemplateMesynthes, Ltd. · 2010
  • K092096Endoform Dermal TemplateMesynthes, Ltd. · 20103 recalls

All 2 as Mesynthes, Ltd. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K092096Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a…Nov 27, 2018Class II
  • K092096Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a…Nov 27, 2018Class II
  • K092096Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a…Nov 27, 2018Class II