KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)— 510(k) K251731
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K251731 for KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612), Substantially Equivalent on 2025-12-05. Applicant: Karl Storz SE & CO. KG.
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Code EOQ
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tuttlingen, DE
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.