SPARTA BRONCHIAL BRUSH— 510(k) K781365

Substantially Equivalent

Sparta Instrument Corp.

FDA 510(k) clearance K781365 for SPARTA BRONCHIAL BRUSH, Substantially Equivalent on 1978-08-14. Applicant: Sparta Instrument Corp..

Clearance details

Applicant: Sparta Instrument Corp.
Product code: Code KTI
Advisory panel: Ear, Nose, Throat
Date received: 1978-08-07
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

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.