510(k) Report

FDA applicant

S&G Biotech, Inc.

Yongin-Si, KR2 decisions2023–20250 recalls

FDA records 2 decisions for S&G Biotech, Inc. (Yongin-Si, KR) from 2023 to 2025: 2 510(k) clearances. All are in product code FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 2 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 S&G Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12025: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — S&G Biotech, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K223354EGIS Biliary Single Bare StentS&G Biotech, Inc. · 20231cites it

What has FDA decided for it lately?

  • K242845EGIS Biliary Double Bare Stent (BDB080405)S&G Biotech, Inc. · 2025
  • K223354EGIS Biliary Single Bare StentS&G Biotech, Inc. · 2023

All 2 as S&G Biotech, Inc. →