FDA 510(k)

ENDOtube

K-Number: K203350 · 2021-09-29

ApplicantNissha Medical Technologies Sas

Decision Date2021-09-29

Product CodeOCX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENDOtube is the device name listed in this FDA 510(k) record. The listed applicant is Nissha Medical Technologies Sas. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K203350. 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 ENDOtube?

ENDOtube is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Nissha Medical Technologies Sas. The 510(k) number is K203350.

When did ENDOtube receive FDA 510(k) clearance?

ENDOtube received FDA 510(k) clearance on 2021-09-29, under 510(k) number K203350.

Who is the listed applicant for ENDOtube?

The FDA 510(k) record lists Nissha Medical Technologies Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOtube?

The FDA product code for ENDOtube is OCX.

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 Corporation K251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation K242586ArgoCap (200.52)Ovesco Endoscopy AG K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems Corporation K241874Aspiration 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.