510(k) Report

FDA applicant

Aponos Medical Corp.

Kingston, NH1 decision2012–20121 recall

FDA records 1 decision for Aponos Medical Corp. (Kingston, NH) in 2012: 1 510(k) clearance. All are in product code PKL (Hemostatic Metal Clip For The Gi Tract). Its devices cite 1 predicate, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Aponos Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2012high 1 (2019) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Aponos Medical Corp. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PKLHemostatic Metal Clip For The Gi Tract1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K120814Padlock Clip-12Aponos Medical Corp. · 20121cites it

What has FDA decided for it lately?

  • K120814Padlock Clip-12Aponos Medical Corp. · 20121 recall

The one decision as Aponos Medical Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K120814US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is…Feb 4, 2019Class II