KARL STORZ TIPCAM1 Rubina— 510(k) K262547
Substantially EquivalentKALR STORZ SE & Co. KG
FDA 510(k) clearance K262547 for KARL STORZ TIPCAM1 Rubina, Substantially Equivalent on 2026-09-21. Applicant: KALR STORZ SE & Co. KG. Device class: 2.
Summary
KARL STORZ TIPCAM1 Rubina is filed under product code OWN (Confocal Optical Imaging). The record spells the applicant "KALR STORZ SE & Co. KG". It doesn't describe the device beyond its name and code.
Class II, 21 CFR 876.1500. The Cardiovascular review panel handled it as a Traditional 510(k), though the record lists Gastroenterology, Urology as the classification panel. The decision was Substantially Equivalent.
The applicant filed from Tuttlingen, Germany. The decision came 60 calendar days after FDA received it (July 23 to September 21, 2026).
Clearance details
- Applicant
- KALR STORZ SE & Co. KG
- Product code
- Product code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
Recent devices under product code OWN
view allAdverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.