PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing— 510(k) K210135

Substantially Equivalent

3M Healthcare Business Group

FDA 510(k) clearance K210135 for PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing, Substantially Equivalent on 2022-02-24. Applicant: 3M Healthcare Business Group.

Clearance details

Applicant: 3M Healthcare Business Group
Product code: Code FRO
Advisory panel: Unknown
Date received: 2021-01-19
Decision date: 2022-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, Bracknell Forest, GB

Download summary PDF View on FDA.gov ↗

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.