510(k) Report

FDA applicant

Mederi Therapeutics, Inc.

Shelton, CT2 decisions2011–20151 recall

FDA records 2 decisions for Mederi Therapeutics, Inc. (Shelton, CT) from 2011 to 2015: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 Mederi Therapeutics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 12015: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2011high 1 (2017) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Mederi Therapeutics, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K152317Stretta CatheterMederi Therapeutics, Inc. · 20151 recall
  • K103017Mederi Therapeutics RF Generator Control ModuleMederi Therapeutics, Inc. · 2011

All 2 as Mederi Therapeutics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K152317Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1…Apr 3, 2017Class II