SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

K233225 is the FDA 510(k) clearance record for SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), a class II device, cleared for Schoelly Fiberoptic GmbH on 2024-06-20 under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 15 510(k) clearances for Schoelly Fiberoptic GmbH, from 1999-02-09 to 2024-06-20. As of 2026-09-10, FDA records show no recalls naming K233225.