LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES— 510(k) K953368
Substantially EquivalentKarl Storz Endoskop GmbH
FDA 510(k) clearance K953368 for LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES, Substantially Equivalent on 1995-09-18. Applicant: Karl Storz Endoskop GmbH.
Clearance details
- Applicant
- Karl Storz Endoskop GmbH
- Product code
- Code BTR
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Adverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
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.