FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
K Number: K221591
·
Decision Feb 23, 2023
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
12
Review Days
266
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Basic Information
- Device Name
- Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
- K Number
- K221591
- 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
- June 2, 2022
- Decision Date
- February 23, 2023
- 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 |
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Other Clearances by Schoelly Fiberoptic GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | Jun 20, 2024 | 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 |