Medical Device Manufacturer · US , Ayer , MA

Schoelly Fiberoptic GmbH - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1999

Recent clearances: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source, TipVision Videoscope System (TipVision VideoScope 0°/30°

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Schoelly Fiberoptic GmbH Obstetrics & Gynecology ✕

3 devices

1-3 of 3

Cleared Mar 12, 2021

TipVision Videoscope System (TipVision VideoScope 0°/30°

Obstetrics & Gynecology · 270d

Cleared Oct 08, 2020

Schoelly Cystoscopes/Hysteroscopes and Accessories

Obstetrics & Gynecology · 85d

Cleared Mar 09, 2015

Schoelly Cystoscopes/Hysteroscopes and Accessories

Obstetrics & Gynecology · 45d