FET — Endoscopic Video Imaging System/Component, Gastroenterology-Urology Class II

FDA Device Classification

Classification Details

Product Code
FET
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251734proverum limitedProVee Video Processing Unit (PV-003)September 24, 2025
K250462univlabs technologies private limitedUL UHD-Clear View 4K Camera System (UL-3Chip 4K)August 11, 2025
K250204shenzhen sophway technology coEndoscopic Camera SystemJuly 1, 2025
K243260fujifilm corporationFUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RApril 11, 2025
K242067olympus corporations of the americasVISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHApril 2, 2025
K243321guangzhou red pine medical instrument coEndoscopic Video Image Processor (RP-IPD-V1000F)February 7, 2025
K241532shanghai seegen photoelectric technology coFlexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)October 22, 2024
K241371olympus medical systems corporationVISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)July 3, 2024
K222584olympus medical systems corporationEVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DApril 26, 2023
K212808richard wolf medical instruments corporationLogic Hd camera head green, System greenJune 14, 2022
K221174karl storz endoscopy americaTelepack +May 13, 2022
K211332richard wolf medical instruments corporationD Camera ControllerOctober 1, 2021
K202646olympus medical systemsVisera Elite II Video System CenterOctober 29, 2020
K201135karl storz endoscopy-americaImage1 S CCU, Image1 S 4U Camera HeadSeptember 1, 2020
K201200olympus medical systemsVisera Elite II Video System CenterJuly 22, 2020
K200617richard wolf medical instruments corporationLogic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera ConJune 23, 2020
K192286fujifilm corporationFUJIFILM EP-6000 Video ProcessorMay 1, 2020
K193235karl storz endoscopy americaTelepack +December 20, 2019
K190449olympus medical systemsVisera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable CamerAugust 30, 2019
K190648zhuhai pusen medical technology coPusen Eview Medical Video Endoscope Image ProcessorMarch 29, 2019