ALGS2 Ag Alginate Wound Dressing Rx +3 more— 510(k) K233111

Name: FDA 510(k) clearance K233111
Creator: U.S. Food and Drug Administration
Published: 2024-05-24

Substantially Equivalent

Foshan United Medical Technologies, Ltd.

FDA 510(k) clearance K233111 for ALGS2 Ag Alginate Wound Dressing Rx +3 more, Substantially Equivalent on 2024-05-24. Applicant: Foshan United Medical Technologies, Ltd.. Device class: Unclassified.

Clearance details

Device name as filed: ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
Applicant: Foshan United Medical Technologies, Ltd.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2023-09-27
Decision date: 2024-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangdong Province, CN

Download summary PDF View on FDA.gov ↗

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K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

More clearances from Foshan United Medical Technologies, Ltd.

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K172570 — ALGS6 Ag Alginate Wound Dressing2018-05-11
K143124 — KA01 Chitosan Wound Dressing2015-01-26

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.