FDA 510(k)

Sistema AquaShield CO2 ; Sistema AquaShield CO2 - PENTAX ; Sistema AquaShield CO2 - Fujifilm

N.º K: K182258 · 2018-09-21

SolicitanteUnited States Endoscopy Group, Inc.

Fecha de decisión2018-09-21

Código de productoFEQ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K182258. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm?

AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K182258.

When did AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm receive FDA 510(k) clearance?

AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm received FDA 510(k) clearance on 2018-09-21, under 510(k) number K182258.

Who is the listed applicant for AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm?

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

What is the FDA product code for AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm?

The FDA product code for AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm is FEQ.

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Otros registros que enlistan a United States Endoscopy Group, Inc. como solicitante

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Dispositivos relacionados (Código: FEQ)

K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation K191559Sistema AquaShield CO2, Sistema AquaShield CO2-PENTAX, Sistema AquaShield CO2-FUJIFILMUnited States Endoscopy Group, Inc.K173650Sistema AquaShield CO2- FujifilmUnited States Endoscopy Group, Inc.K163424Sistema AquaShield - PENTAX, Sistema AquaShield CO2 - PENTAX, Sistema AquaShield CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc.

Fuente oficial

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