WATER JEL STERILE GEL-SOAKED BURN DRESSING— 510(k) K885321

Substantially Equivalent for Some Indications

Pfizer Pharmaceuticals

FDA 510(k) clearance K885321 for WATER JEL STERILE GEL-SOAKED BURN DRESSING, Substantially Equivalent for Some Indications on 1989-03-22. Applicant: Pfizer Pharmaceuticals.

Clearance details

Applicant: Pfizer Pharmaceuticals
Product code: Code FRO
Advisory panel: Unknown
Date received: 1988-12-28
Decision date: 1989-03-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ny, NY, 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.