SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA— 510(k) K991287

Substantially Equivalent

Advanced Medical Solutions Group Plc

FDA 510(k) clearance K991287 for SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA, Substantially Equivalent on 1999-06-29. Applicant: Advanced Medical Solutions Group Plc.

Clearance details

Applicant: Advanced Medical Solutions Group Plc
Product code: Code FRO
Advisory panel: Unknown
Date received: 1999-04-14
Decision date: 1999-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winsford, Cheshire, 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.