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FDA 510(k)

Endorate Valve Sets

K-Number: K181509 · 2018-07-06

ApplicantSmartdata Suzhou Co., Ltd.
Decision Date2018-07-06
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endorate Valve Sets is the device name listed in this FDA 510(k) record. The listed applicant is Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K181509. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endorate Valve Sets?

Endorate Valve Sets is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Smartdata Suzhou Co., Ltd.. The 510(k) number is K181509.

When did Endorate Valve Sets receive FDA 510(k) clearance?

Endorate Valve Sets received FDA 510(k) clearance on 2018-07-06, under 510(k) number K181509.

Who is the listed applicant for Endorate Valve Sets?

The FDA 510(k) record lists Smartdata Suzhou Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endorate Valve Sets?

The FDA product code for Endorate Valve Sets is OCX.

Other records listing Smartdata Suzhou Co., Ltd. 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.

K191366Vacutore Air/Water Bottle TubingK191231Andorate Auxiliary Water Connector, Andorate Valves SetK182998Andorate Auxiliary Water Connector

Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, Inc.

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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