SHIKANI-FRENCH SPEAKING VALVE— 510(k) K982128
Substantially EquivalentPilling Weck Surgical
FDA 510(k) clearance K982128 for SHIKANI-FRENCH SPEAKING VALVE, Substantially Equivalent on 1998-10-23. Applicant: Pilling Weck Surgical. Device class: 2.
Clearance details
- Applicant
- Pilling Weck Surgical
- Product code
- Code JOH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Washington, PA, US
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More clearances from Pilling Weck Surgical
view allAdverse 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, through . 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.