DeviceClearance

Biatain Fiber Ag (5 models)— 510(k) K231953

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K231953 for Biatain Fiber Ag (5 models), Substantially Equivalent on 2024-03-22. Applicant: Coloplast Corp.. Device class: Unclassified.

Clearance details

Device name as filed
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
Applicant
Coloplast Corp.
Product code
Code FRO
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

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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, through . 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.