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— 510(k) K233111

Substantially Equivalent

Foshan United Medical Technologies, Ltd.

FDA 510(k) clearance K233111 for 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, Substantially Equivalent on 2024-05-24. Applicant: Foshan United Medical Technologies, Ltd..

Clearance details

Applicant: Foshan United Medical Technologies, Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2023-09-27
Decision date: 2024-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangdong Province, CN

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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.