Product Code: FEQ FDA class 2 21 CFR 876.1500

Pump, Air, Non-Manual, For Endoscope

Gastroenterology, Urology

The Non-Manual Air Pump for Endoscope is a powered accessory that provides controlled air insufflation during endoscopic procedures to distend body cavities for improved visualization. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is FEQ, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FEQ
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220395	EndoGator Endoscopy Irrigation Tubing	Mar 11, 2022	Substantially Equivalent	STERIS Corporation
K191559	AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM	Aug 01, 2019	Substantially Equivalent	United States Endoscopy Group, Inc.
K182258	AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm	Sep 21, 2018	Substantially Equivalent	United States Endoscopy Group, Inc.
K173650	AquaShield System CO2- Fujifilm	Jan 05, 2018	Substantially Equivalent	United States Endoscopy Group, Inc.
K163424	AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON	Jan 04, 2017	Substantially Equivalent	United State Endoscopy Group, Inc.
K162152	Erbes CO2 Tubing/Cap Sets	Aug 31, 2016	Substantially Equivalent	Erbe USA, Inc.
K161482	EndoChoice Water Bottle Cap Irrigation System	Jun 27, 2016	Substantially Equivalent	Endochoice, Inc.
K153588	EndoChoice Water Bottle Cap System	Feb 24, 2016	Substantially Equivalent	Endochoice, Inc.
K153362	AquaShield system CO2, AquaShield system-PENTAX	Dec 16, 2015	Substantially Equivalent	United States Endoscopy Group, Inc.
K142155	ENDOCHOICE WATER BOTTLE CAP SYSTEM	Jan 20, 2015	Substantially Equivalent	Endochoice, Inc.
K133747	ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM	Jan 08, 2014	Substantially Equivalent	Endochoice, Inc.
K132340	ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1	Dec 17, 2013	Substantially Equivalent	Erbe USA, Inc.
K120862	WATER BOTTLE CAP IRRIGATON SYSTEM	Nov 27, 2012	Substantially Equivalent	Endochoice, Inc.
K120123	AQUASHIELD CO2 SYSTEM	Mar 28, 2012	Substantially Equivalent	United States Endoscopy Group, Inc.
K112576	ENDOCHOICE WATER BOTTLE CAP SYSTEM	Jan 25, 2012	Substantially Equivalent	Endochoice, Inc.
K103696	ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES	Mar 22, 2011	Substantially Equivalent	Erbe USA, Inc.
K100899	OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2	Sep 13, 2010	Substantially Equivalent	Keymed (Medical & Industrial Equipment), Ltd.
K101146	WATER BOTTLE CAP SYSTEM	Jul 16, 2010	Substantially Equivalent	United States Endoscopy Group, Inc.
K100803	OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1	Apr 22, 2010	Substantially Equivalent	Keymed, Inc.
K092429	ENDOGATOR	Nov 19, 2009	Substantially Equivalent	Byrne Medical, Inc.
K000948	OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1	May 12, 2000	Substantially Equivalent	Keymed (Medical & Industrial Equipment), Ltd.