FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
K Number: K233225
·
Decision Jun 20, 2024
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
12
Review Days
266
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
- K Number
- K233225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schoelly Fiberoptic GmbH
- Date Received
- September 28, 2023
- Decision Date
- June 20, 2024
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tech-Image Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TroKit Laparoscope Lens Wiper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Inno-Port Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Schoelly Fiberoptic GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | Feb 23, 2023 | Substantially Equivalent |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Mar 12, 2021 | Substantially Equivalent |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Oct 8, 2020 | Substantially Equivalent |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | Feb 9, 2016 | Substantially Equivalent |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Mar 9, 2015 | Substantially Equivalent |
| K143673 | CMOS Video Nasopharyngoscope System | Mar 4, 2015 | Substantially Equivalent |
| K142249 | SCHOELLY SINUSCOPE | Jan 27, 2015 | Substantially Equivalent |
| K143221 | Schoelly Laparoscope | Dec 5, 2014 | Substantially Equivalent |
| K132009 | CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM | Apr 9, 2014 | Substantially Equivalent |
| K992362 | FLEXISCOPE IQ 101 | Aug 5, 1999 | Substantially Equivalent |