Roosin Collagen Powder— 510(k) K254034

Name: FDA 510(k) clearance K254034
Creator: U.S. Food and Drug Administration
Published: 2026-06-03

Substantially Equivalent

Roosin Medical Co., Ltd.

FDA 510(k) clearance K254034 for Roosin Collagen Powder, Substantially Equivalent on 2026-06-03. Applicant: Roosin Medical Co., Ltd.. Device class: Unclassified.

Clearance details

Applicant: Roosin Medical Co., Ltd.
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-12-16
Decision date: 2026-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taizhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGN

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K260652 — ColActive Plus2026-09-09
K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more2026-08-27
K260596 — Collagen Wound Powder2026-07-02
K260669 — Endoform Dermal Template2026-06-24
K253521 — ECMT-100 WMD2026-06-18

More clearances from Roosin Medical Co., Ltd.

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K253974 — Roosin Collagen Dressing2026-06-03
K231088 — Copper Foam Dressing (Prescription and OTC)2024-01-11
K230190 — Polyver Silver Alginate Dressing (Prescription and OTC)2023-11-17
K181478 — Roosin Xeroform Petrolatum Dressing2019-09-13

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.