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

Name: FDA 510(k) clearance K991287
Creator: U.S. Food and Drug Administration
Published: 1999-06-29

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. Device class: Unclassified.

Clearance details

Applicant: Advanced Medical Solutions Group Plc
Product code: Code FRO
Device class: Unclassified
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 ↗

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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, 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.

Clearance details

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Adverse events under product code FRO