SANAPLAST— 510(k) K881397

Substantially Equivalent

Nebo Industries

FDA 510(k) clearance K881397 for SANAPLAST, Substantially Equivalent on 1988-06-14. Applicant: Nebo Industries.

Clearance details

Applicant: Nebo Industries
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1988-04-04
Decision date: 1988-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fountain Green, UT, US

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.