510(k) Report

FDA applicant

Surgical Devices, A Global Business Unit Covidien

North Haven, CT3 decisions2008–20092 recalls

FDA records 3 decisions for Surgical Devices, A Global Business Unit Covidien (North Haven, CT) from 2008 to 2009: 3 510(k) clearances. Most are in product codes GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) and GDW (Staple, Implantable). Its devices cite 5 predicates, 0 of them its own earlier devices. 2 recalls are 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 Surgical Devices, A Global Business Unit Covidien’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2008: 12009: 2
2008high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2018

2018: 2
2008high 2 (2018) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Surgical Devices, A Global Business Unit Covidien by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgical Devices, A Global Business…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GATSuture, Nonabsorbable, Synthetic, Polyethylene2decisions
  • GDWStaple, Implantable1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K091016Covidien Sports Surgery as Meniscal Repair Device with High Strength SutureSurgical Devices, A Global Business Unit Covidien · 2009
  • K083781Eea Hemorrhoid Stapler & AccessoriesSurgical Devices, A Global Business Unit Covidien · 20092 recalls
  • K082535Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien · 2008

All 3 as Surgical Devices, A Global Business Unit Covidien →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K083781EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product…Apr 9, 2018Class II
  • K083781EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product…Apr 9, 2018Class II