Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bio Guard Air/Water & Suction Valves

K-Number: K192059 · 2019-09-17

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2019-09-17
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bio Guard Air/Water & Suction Valves is a medical device manufactured by United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2019-09-17 under approval number K192059. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bio Guard Air/Water & Suction Valves?

Bio Guard Air/Water & Suction Valves is a medical device that received FDA 510(k) clearance on 2019-09-17. It is manufactured by United States Endoscopy Group, Inc.. The 510(k) number is K192059.

When was Bio Guard Air/Water & Suction Valves approved by the FDA?

Bio Guard Air/Water & Suction Valves received FDA 510(k) clearance on 2019-09-17, under approval number K192059.

What company makes Bio Guard Air/Water & Suction Valves?

Bio Guard Air/Water & Suction Valves is manufactured by United States Endoscopy Group, Inc..

What is the FDA product code for Bio Guard Air/Water & Suction Valves?

The FDA product code for Bio Guard Air/Water & Suction Valves is ODC.

Other Devices by United States Endoscopy Group, Inc.

K172805gi-4000 Electrosurgical Generator K163495AdvanCE capsule endoscope delivery device K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear K182909Roth Net Retriever Product Line K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm K173650AquaShield System CO2- Fujifilm

View all 10 devices →

Related Devices (Code: ODC)

K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc. K162142Accessory Irrigation AdapterWilson-Cook Medical, Inc. K181712San Antonio StopcockCook Incorporated K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated K192258Disposable Valve SetsZhejiang Chuangxiang Medical Technology Co., Ltd. K191231Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd.

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.

↑