KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN— 510(k) K925748
Substantially EquivalentKendall Healthcare Products Co. Div.Of Tyco Health
FDA 510(k) clearance K925748 for KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN, Substantially Equivalent on 1993-01-13. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health.
Clearance details
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Product code
- Code GBX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Adverse events under product code GBX
product code GBX- Death
- 16
- Injury
- 583
- Malfunction
- 3,578
- Other
- 1
- Total
- 4,178
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.