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FDA 510(k)

AQUASHIELD CO2 SYSTEM

K-Number: K120123 · 2012-03-28

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2012-03-28
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AQUASHIELD CO2 SYSTEM 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 2012-03-28 under 510(k) number K120123. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUASHIELD CO2 SYSTEM?

AQUASHIELD CO2 SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K120123.

When did AQUASHIELD CO2 SYSTEM receive FDA 510(k) clearance?

AQUASHIELD CO2 SYSTEM received FDA 510(k) clearance on 2012-03-28, under 510(k) number K120123.

Who is the listed applicant for AQUASHIELD CO2 SYSTEM?

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 CO2 SYSTEM?

The FDA product code for AQUASHIELD CO2 SYSTEM is FEQ.

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Other records listing United States Endoscopy Group, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192265gi-4000 Electrosurgical GeneratorK200745Lariat, Hot/Cold SnareK192059Bio Guard Air/Water & Suction ValvesK191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMK182909Roth Net Retriever Product LineK182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm

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Related Devices (Code: FEQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220395EndoGator Endoscopy Irrigation TubingSTERIS CorporationK191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc.K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc.K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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