SHIKANI SPEAKING VALVE— 510(k) K100995

Substantially Equivalent

Shikani Medical, LLC

FDA 510(k) clearance K100995 for SHIKANI SPEAKING VALVE, Substantially Equivalent on 2010-06-25. Applicant: Shikani Medical, LLC.

Clearance details

Applicant: Shikani Medical, LLC
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2010-04-09
Decision date: 2010-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.