KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
FDA 510(k) clearance K233333 · decided 2023-11-21
Clearance details
- K-number
- K233333
- Device name
- KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
- Applicant
- Karl Storz SE & CO. KG
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2023-11-21
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- OWN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.