IPM Wound Gel Bio, IPM Derm Gel Bio— 510(k) K143527

Substantially Equivalent

Glycobiosciences, Inc.

FDA 510(k) clearance K143527 for IPM Wound Gel Bio, IPM Derm Gel Bio, Substantially Equivalent on 2015-04-20. Applicant: Glycobiosciences, Inc..

Clearance details

Applicant: Glycobiosciences, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2014-12-12
Decision date: 2015-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Georgetown, CA

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.