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FDA 510(k)

SmartStart Air/Water and Suction Valves

K-Number: K160403 · 2016-05-19

ApplicantEndochoice, Inc.
Decision Date2016-05-19
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SmartStart Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K160403. 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 SmartStart Air/Water and Suction Valves?

SmartStart Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Endochoice, Inc.. The 510(k) number is K160403.

When did SmartStart Air/Water and Suction Valves receive FDA 510(k) clearance?

SmartStart Air/Water and Suction Valves received FDA 510(k) clearance on 2016-05-19, under 510(k) number K160403.

Who is the listed applicant for SmartStart Air/Water and Suction Valves?

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

What is the FDA product code for SmartStart Air/Water and Suction Valves?

The FDA product code for SmartStart Air/Water and Suction Valves is ODC.

Other records listing Endochoice, 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.

K160275Fuse Endoscopic System with FuseBox ProcessorK161482EndoChoice Water Bottle Cap Irrigation SystemK161167Seal Single-Use Biopsy ValveK153588EndoChoice Water Bottle Cap SystemK151475EndoChoice Select Injection Needle

Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

Official Source

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

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