510(k) Report

FDA applicant

Tissue Regenix Group Plc

York, GB1 decision2016–20160 recalls

FDA records 1 decision for Tissue Regenix Group Plc (York, GB) in 2016: 1 510(k) clearance. All are in product code FTM (Mesh, Surgical). Its devices cite 1 predicate, 0 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 Tissue Regenix Group Plc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Tissue Regenix Group Plc by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FTMMesh, Surgical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc · 2016

The one decision as Tissue Regenix Group Plc →

Other applicant names beginning “Tissue”

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

Tissue Technologies, Inc. 9Tissue Culture Innovations 6Tissue Science Laboratories, Plc 6Tissue Regeneration Technologies, LLC 5Tissue Technologies Holdings, LLC 2Tissue Seal, LLC 1Tissue Medical Lasers, Inc. 1Tissue Regeneration Technologies, LLC Dba AS Softwave… 1Tissue Culture Biologicals 1Tissue Differentiation Intelligence, LLC 1Tissue Culture Biotec, Inc. 1Tissue Repair Company 1