510(k) clearance
KARL STORZ TIPCAM1 Rubina
- 510(k) number
- K262547
- Applicant
- KALR STORZ SE & Co. KG
- Decision date
- Sep 21, 2026
- Date received
- Jul 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OWN
- Device type
- Confocal Optical Imaging
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Tuttlingen, DE