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., Endochoice, Inc. and Erbe USA, Inc..

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
Cleared Jan 04, 2017
AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
K163424
United State Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 31, 2016
Erbe’s CO2 Tubing/Cap Sets
K162152
Erbe USA, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 27, 2016
EndoChoice Water Bottle Cap Irrigation System
K161482
Endochoice, Inc.
Gastroenterology & Urology · 27d
Cleared Feb 24, 2016
EndoChoice Water Bottle Cap System
K153588
Endochoice, Inc.
Gastroenterology & Urology · 70d
Cleared Dec 16, 2015
AquaShield system CO2, AquaShield system-PENTAX
K153362
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 26d
Cleared Jan 20, 2015
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K142155
Endochoice, Inc.
Gastroenterology & Urology · 167d
Cleared Jan 08, 2014
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
K133747
Endochoice, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 17, 2013
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
K132340
Erbe USA, Inc.
Gastroenterology & Urology · 144d
Cleared Nov 27, 2012
WATER BOTTLE CAP IRRIGATON SYSTEM
K120862
Endochoice, Inc.
Gastroenterology & Urology · 250d
Cleared Mar 28, 2012
AQUASHIELD CO2 SYSTEM
K120123
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 71d
Cleared Jan 25, 2012
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K112576
Endochoice, Inc.
Gastroenterology & Urology · 141d
Cleared Mar 22, 2011
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
K103696
Erbe USA, Inc.
Gastroenterology & Urology · 95d
Cleared Jul 16, 2010
WATER BOTTLE CAP SYSTEM
K101146
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 84d
Cleared Apr 22, 2010
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
K100803
Keymed, Inc.
Gastroenterology & Urology · 31d

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.