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 General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared Jun 20, 2024

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit,...

General & Plastic Surgery · 266d

Cleared Feb 23, 2023

Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic...

General & Plastic Surgery · 266d

Cleared Dec 05, 2014

Schoelly Laparoscope

General & Plastic Surgery · 25d