510(k) Report

FDA applicant

Unilene Sac

Greenwood Village, CO2 decisions2010–20130 recalls

FDA records 2 decisions for Unilene Sac (Greenwood Village, CO) from 2010 to 2013: 2 510(k) clearances. Most are in product codes NEW (Suture, Surgical, Absorbable, Polydioxanone) and GAR (Suture, Nonabsorbable, Synthetic, Polyamide). 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 Unilene Sac’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12013: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Unilene Sac 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?

  • NEWSuture, Surgical, Absorbable, Polydioxanone1decision
  • GARSuture, Nonabsorbable, Synthetic, Polyamide1decision

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.

  • K123034Vital Sutures Suturex Cirugia Peruana SutumedUnilene Sac · 20131cites it

What has FDA decided for it lately?

  • K123034Vital Sutures Suturex Cirugia Peruana SutumedUnilene Sac · 2013
  • K100780Vital Sutures, Suturex, Cirugia PeruanaUnilene Sac · 2010

All 2 as Unilene Sac →