Karl Storz Endovision, Inc.
FDA Regulatory Profile
Karl Storz Endovision, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1333-2016, Class II) was initiated on February 29, 2016. Its most recent 510(k) clearance was granted on June 10, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1333-2016 | Class II | ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning var | February 29, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232911 | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Fle | June 10, 2024 |