510(k) Report

FDA applicant

Medchannel, LLC

Boston, MA3 decisions2005–20060 recalls

FDA records 3 decisions for Medchannel, LLC (Boston, MA) from 2005 to 2006: 3 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and GDW (Staple, Implantable). Its devices cite 3 predicates, 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 Medchannel, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medchannel, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medchannel, 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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • GDWStaple, Implantable1decision
  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K060494Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 20062cite it
  • K061831Medchannel HTS SystemMedchannel, LLC · 20061cites it

What has FDA decided for it lately?

  • K061831Medchannel HTS SystemMedchannel, LLC · 2006
  • K060494Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
  • K051700Opticlean Lens Irrigator & Optidock Tissue LigatorMedchannel, LLC · 2005

All 3 as Medchannel, LLC →