510(k) Report

FDA applicant

Covidien, LLC ( Formerly Beacon Endoscopic Corp.)

Auburndale, MA2 decisions2014–20150 recalls

FDA records 2 decisions for Covidien, LLC ( Formerly Beacon Endoscopic Corp.) (Auburndale, MA) from 2014 to 2015: 2 510(k) clearances. All are in product code FCG (Biopsy Needle). Its devices cite 4 predicates, 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Covidien, LLC ( Formerly Beacon Endoscopic Corp.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Covidien, LLC ( Formerly Beacon Endoscopic Corp.) by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FCGBiopsy Needle2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 20152cite it
  • K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 20141cites it

What has FDA decided for it lately?

  • K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
  • K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2014

All 2 as Covidien, LLC ( Formerly Beacon Endoscopic Corp.) →

Other applicant names beginning “Covidien”

FDA records each applicant name separately; these may or may not be the same firm.

Covidien 227Covidien, Formerly US Surgical A Divison of Tyco H 13Covidien Lp, Formerly Registered AS United States 8Covidien, Formerly Valleylab, A Division of Tyco H 6Covidien, Formerly Nellcor Puritan Bennett, Inc. 5Covidien Lp, Formerly Registered AS Tyco Healthcar 4Covidien Lp, Formerly Registered AS Kendall 3Covidien (Part of Medtronic) 2Covidien, LLC, Formerly Registered AS Tyco Healthca 2Covidien Lp, Formerly Know AS Valleylab, A Divison 2Covidien (Dba Medtronic) 1Covidien UK Manufacturing, Ltd. 1