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FDA 510(k)

Disposable Endoscope Valve Sets

K-Number: K220884 · 2023-01-17

ApplicantSml Med-Tech Solutions Limited
Decision Date2023-01-17
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscope Valve Sets is the device name listed in this FDA 510(k) record. The listed applicant is Sml Med-Tech Solutions Limited. It received FDA 510(k) clearance on 2023-01-17 under 510(k) number K220884. 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 Disposable Endoscope Valve Sets?

Disposable Endoscope Valve Sets is a medical device that received FDA 510(k) clearance on 2023-01-17. The listed applicant is Sml Med-Tech Solutions Limited. The 510(k) number is K220884.

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

Disposable Endoscope Valve Sets received FDA 510(k) clearance on 2023-01-17, under 510(k) number K220884.

Who is the listed applicant for Disposable Endoscope Valve Sets?

The FDA 510(k) record lists Sml Med-Tech Solutions Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscope Valve Sets?

The FDA product code for Disposable Endoscope Valve Sets is ODC.

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

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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