FDA 510(k)

Système AquaShield - PENTAX, Système AquaShield CO2 - PENTAX, Système AquaShield CO2 - FUJINON

Numéro K : K163424 · 2017-01-04

DemandeurUnited State Endoscopy Group, Inc.

Date de décision2017-01-04

Code produitFEQ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is the device name listed in this FDA 510(k) record. The listed applicant is United State Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K163424. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON?

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is United State Endoscopy Group, Inc.. The 510(k) number is K163424.

When did AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON receive FDA 510(k) clearance?

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON received FDA 510(k) clearance on 2017-01-04, under 510(k) number K163424.

Who is the listed applicant for AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON?

The FDA 510(k) record lists United State Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON?

The FDA product code for AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is FEQ.

Essais cliniques associés

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Dispositifs connexes (Code : FEQ)

K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation K191559Système AquaShield CO2, Système AquaShield CO2-PENTAX, Système AquaShield CO2-FUJIFILMUnited States Endoscopy Group, Inc.K182258Système AquaShield CO2 ; Système AquaShield CO2 - PENTAX ; Système AquaShield CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650Système AquaShield CO2- FujifilmUnited States Endoscopy Group, Inc.K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc.

Source officielle

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