510(k) Report

FDA applicant

Agnes Medical Co., Ltd.

Seongnam-Si, KR7 decisions2019–20250 recalls

FDA records 7 decisions for Agnes Medical Co., Ltd. (Seongnam-Si, KR) from 2019 to 2025: 7 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 248 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 8 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, general and plastic surgery panel, where it files most

How often FDA has decided Agnes Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2019: 12022: 12023: 12024: 12025: 3
2019high 3 (2025) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Agnes Medical Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Agnes Medical Co., Ltd.’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories7decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 248 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 1 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K242469RFMagik LiteAgnes Medical Co., Ltd. · 20252cite it
  • K192728AgnesAgnes Medical Co., Ltd. · 20192cite it
  • K223805AgnesAgnes Medical Co., Ltd. · 20231cites it
  • K203013AGNESAgnes Medical Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K250217AGNES UltraAgnes Medical Co., Ltd. · 2025
  • K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL…Agnes Medical Co., Ltd. · 2025
  • K242469RFMagik LiteAgnes Medical Co., Ltd. · 2025
  • K230837PlazMagikAgnes Medical Co., Ltd. · 2024
  • K223805AgnesAgnes Medical Co., Ltd. · 2023
  • K203013AGNESAgnes Medical Co., Ltd. · 2022
  • K192728AgnesAgnes Medical Co., Ltd. · 2019

All 7 as Agnes Medical Co., Ltd. →