SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
FDA 510(k) K233225 · Schoelly Fiberoptic GmbH
510(k) numberK233225
Submission
- Device name
- SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
- Applicant
- Schoelly Fiberoptic GmbH
Denzlingen, DE - Received
- September 28, 2023
- Decision date
- June 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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 at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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|---|---|---|
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…GCJ · Traditional | 02/23/2023SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | 03/12/2021SE |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH · Traditional | 10/08/2020SE |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFGA · Traditional | 02/09/2016SE |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH · Traditional | 03/09/2015SE |
| K143673 | CMOS Video Nasopharyngoscope SystemEOB · Special | 03/04/2015SE |
| K142249 | Schoelly SinuscopeEOB · Traditional | 01/27/2015SE |
| K143221 | Schoelly LaparoscopeGCJ · Special | 12/05/2014SE |
| K132009 | Cmos Video Nasopharyngoscope SystemEOB · Traditional | 04/09/2014SE |
| K992362 | Flexiscope Iq 101FET · Traditional | 08/05/1999SE |
Questions and answers
When was SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) cleared by the FDA?
SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) (K233225) received a 510(k) decision of Substantially Equivalent on June 20, 2024, 266 days after the submission was received.
What is the product code of K233225?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.