510(k) Report

FDA applicant

Medeon Biodesign, Inc.

Taipei, TW7 decisions2015–20200 recalls

FDA records 7 decisions for Medeon Biodesign, Inc. (Taipei, TW) from 2015 to 2020: 7 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and OCW (Endoscopic Tissue Approximation Device). Since 2016 its 510(k)s took a median of 32 days from receipt to decision, against 69 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 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 Medeon Biodesign, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2015: 12016: 22017: 12019: 12020: 2
2015high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

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

Planning a device like Medeon Biodesign, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery5decisions
  • OCWEndoscopic Tissue Approximation Device2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 32 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 69 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K192891Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 20192cite it
  • K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 20172cite it
  • K160117AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. · 20161cites it
  • K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 20151cites it
  • K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 20161cites it

What has FDA decided for it lately?

  • K200902ClickCleanMedeon Biodesign, Inc. · 2020
  • K193652AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. · 2020
  • K192891Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2019
  • K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017
  • K160117AbClose - Port Site Closure DeviceMedeon Biodesign, Inc. · 2016
  • K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
  • K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015

All 7 as Medeon Biodesign, Inc. →