KARL STORZ ICG Imaging System with RUBINA® Lens— 510(k) K254242
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K254242 for KARL STORZ ICG Imaging System with RUBINA® Lens, Substantially Equivalent on 2026-02-26. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Summary
Karl Storz's KARL STORZ ICG Imaging System with RUBINA® Lens is filed under product code OWN, confocal optical imaging. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 876.1500. The General, Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology, Urology as the classification panel.
Karl Storz filed from Tuttlingen, Germany. Review took 59 calendar days (December 29, 2025 to February 26, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Karl 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 allMore clearances from Karl Storz SE & CO. KG
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.