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510(k) K092429

Device
ENDOGATOR
Applicant
BYRNE MEDICAL, INC.
510(k) number
K092429
Product code
FEQ  
Decision
Substantially Equivalent (SESE)
Decision date
2009-11-19
Date received
2009-08-07
Regulation
876.1500
Classification name
Pump, Air, Non-manual, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
DON BYRNE
Address
3150 Pollock Dr. Conroe TX US 77303 77303

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FEQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation2022-03-11
K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc.2019-08-01
K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc.2018-09-21
K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc.2018-01-05
K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc.2017-01-04
K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.2016-08-31
K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc.2016-06-27
K153588EndoChoice Water Bottle Cap SystemEndochoice, Inc.2016-02-24
K153362AquaShield system CO2, AquaShield system-PENTAXUnited States Endoscopy Group, Inc.2015-12-16
K142155ENDOCHOICE WATER BOTTLE CAP SYSTEMEndochoice, Inc.2015-01-20
K133747ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEMEndochoice, Inc.2014-01-08
K132340ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1Erbe USA, Inc.2013-12-17
K120862WATER BOTTLE CAP IRRIGATON SYSTEMEndochoice, Inc.2012-11-27
K120123AQUASHIELD CO2 SYSTEMUnited States Endoscopy Group, Inc.2012-03-28
K112576ENDOCHOICE WATER BOTTLE CAP SYSTEMEndochoice, Inc.2012-01-25

Legacy Summary#

summary

FDA Review#

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