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FDA 510(k)

Erbe’s CO2 Tubing/Cap Sets

K-Number: K162152 · 2016-08-31

ApplicantErbe USA, Inc.
Decision Date2016-08-31
Product CodeFEQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Erbe’s CO2 Tubing/Cap Sets is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K162152. 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 Erbe’s CO2 Tubing/Cap Sets?

Erbe’s CO2 Tubing/Cap Sets is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Erbe USA, Inc.. The 510(k) number is K162152.

When did Erbe’s CO2 Tubing/Cap Sets receive FDA 510(k) clearance?

Erbe’s CO2 Tubing/Cap Sets received FDA 510(k) clearance on 2016-08-31, under 510(k) number K162152.

Who is the listed applicant for Erbe’s CO2 Tubing/Cap Sets?

The FDA 510(k) record lists Erbe USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Erbe’s CO2 Tubing/Cap Sets?

The FDA product code for Erbe’s CO2 Tubing/Cap Sets is FEQ.

Other records listing Erbe USA, 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.

K221177Erbe's Tubing/Cap SetsK191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorK190469ERBEFLO 2 Disposable Tubing SystemK182444ERBEFLO Olympus Scope Port Connector

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.K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, 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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