510(k) Report

FDA applicant

Sewon Cellontech Co., Ltd.

Santa Fe Springs, CA2 decisions2009–20090 recalls

FDA records 2 decisions for Sewon Cellontech Co., Ltd. (Santa Fe Springs, CA) in 2009: 2 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 2 predicates, 0 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

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

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Sewon Cellontech Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K090812Theraform Standard/SheetSewon Cellontech Co., Ltd. · 20091cites it

What has FDA decided for it lately?

  • K090823Theraform BilayerSewon Cellontech Co., Ltd. · 2009
  • K090812Theraform Standard/SheetSewon Cellontech Co., Ltd. · 2009

All 2 as Sewon Cellontech Co., Ltd. →

Other applicant names beginning “Sewon”

FDA records each applicant name separately; these may or may not be the same firm.

Sewon Industry 7Sewon Medical Co. 1