VISCOPASTE ZINC PASTE BANDAGE— 510(k) K863930

Substantially Equivalent for Some Indications

Smith & Nephew, Inc.

FDA 510(k) clearance K863930 for VISCOPASTE ZINC PASTE BANDAGE, Substantially Equivalent for Some Indications on 1986-12-01. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1986-10-08
Decision date: 1986-12-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Massillon, OH, US

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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.