510(k) Report

FDA applicant

Tissue Seal, LLC

Ann Arbor1 decision2007–20070 recalls

FDA records 1 decision for Tissue Seal, LLC (Ann Arbor) in 2007: 1 original PMA approval. All are in product code MPN (Tissue Adhesive For The Topical Approximation…). 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 Seal, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MPNTissue Adhesive For The Topical Approximation Of Skin1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • P050013Histoacryl and Histoacryl Blue Topical Skin AdhesiveTissue Seal, LLC · 20071cites it

What has FDA decided for it lately?

  • P050013Histoacryl and Histoacryl Blue Topical Skin AdhesiveTissue Seal, LLC · 2007

The one decision as Tissue Seal, LLC →

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 Regenix Group Plc 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