FEQ · Class II · 21 CFR 876.1500

FDA Product Code FEQ: Pump, Air, Non-manual, For Endoscope

Leading manufacturers include United States Endoscopy Group, Inc. and STERIS Corporation.

21
Total
21
Cleared
79d
Avg days
2000
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Pump, Air, Non-manual, For Endoscope Devices (Product Code FEQ)

21 devices
1–21 of 21
Cleared Mar 11, 2022
EndoGator Endoscopy Irrigation Tubing
K220395
STERIS Corporation
Gastroenterology & Urology · 28d
Cleared Aug 01, 2019
AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
K191559
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 49d
Cleared Sep 21, 2018
AquaShield System CO2
K182258
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 31d
Cleared Jan 05, 2018
AquaShield System CO2- Fujifilm
K173650
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 38d

About Product Code FEQ - Regulatory Context

510(k) Submission Activity

21 total 510(k) submissions under product code FEQ since 2000, with 21 receiving FDA clearance (average review time: 79 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.