510(k) Report

FDA applicant

Amsel Medical Corporation

Cambridge, MA3 decisions2015–20180 recalls

FDA records 3 decisions for Amsel Medical Corporation (Cambridge, MA) from 2015 to 2018: 3 510(k) clearances. All are in product code FZP (Clip, Implantable). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Amsel Medical”.

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 Amsel Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015: 12017: 12018: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Amsel Medical Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Amsel Medical Corporation’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?

  • FZPClip, Implantable3decisions

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 2 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.

  • K140932Amsel Occluder DeviceAmsel Medical Corporation · 20152cite it

What has FDA decided for it lately?

  • K180650Amsel Endo OccluderAmsel Medical Corporation · 2018
  • K172479Amsel Occluder DeviceAmsel Medical · 2017
  • K140932Amsel Occluder DeviceAmsel Medical Corporation · 2015

All 2 as Amsel Medical Corporation →The one decision as Amsel Medical →