510(k) Report

FDA applicant

Healthtek Microsurgical, Inc.

Burlington, MA1 decision1990–19900 recalls

FDA records 1 decision for Healthtek Microsurgical, Inc. (Burlington, MA) in 1990: 1 510(k) clearance. All are in product code EOB (Nasopharyngoscope (Flexible Or Rigid)). 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, ear, nose and throat panel, where it files most

How often FDA has decided Healthtek Microsurgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Healthtek Microsurgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Healthtek Microsurgical, Inc. 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?

  • EOBNasopharyngoscope (Flexible Or Rigid)1decision

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.

  • K902683Scopescrubber (TM)Healthtek Microsurgical, Inc. · 19901cites it

What has FDA decided for it lately?

  • K902683Scopescrubber (TM)Healthtek Microsurgical, Inc. · 1990

The one decision as Healthtek Microsurgical, Inc. →

Other applicant names beginning “Healthtek”

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

Healthtek, Inc. 9