510(k) Report

FDA applicant

Nelis

Bucheon, KR2 decisions2015–20160 recalls

FDA records 2 decisions for Nelis (Bucheon, KR) from 2015 to 2016: 2 510(k) clearances. Most are in product codes OTJ (Laparoscopic Single Port Access Device) and GCJ (Laparoscope, General & Plastic Surgery). 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 Nelis’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015: 12016: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

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

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Which product codes does it file in?

  • OTJLaparoscopic Single Port Access Device1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

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.

  • K141715Glove PortNelis · 20153cite it

What has FDA decided for it lately?

All 2 as Nelis →