G4Derm / G4Derm Plus Synthetic Wound Matrix— 510(k) K222025

Substantially Equivalent

Gel4med, Inc.

FDA 510(k) clearance K222025 for G4Derm / G4Derm Plus Synthetic Wound Matrix, Substantially Equivalent on 2023-10-11. Applicant: Gel4med, Inc..

Clearance details

Applicant: Gel4med, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2022-07-11
Decision date: 2023-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brighton, MA, US

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.