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FDA 510(k)

Disposable Endoscope Valves Set (AF series)

K-Number: K241285 · 2024-10-01

ApplicantAlton (Shanghai) Medical Instruments Co., Ltd.
Decision Date2024-10-01
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscope Valves Set (AF series) is the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-10-01 under 510(k) number K241285. 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 Valves Set (AF series)?

Disposable Endoscope Valves Set (AF series) is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K241285.

When did Disposable Endoscope Valves Set (AF series) receive FDA 510(k) clearance?

Disposable Endoscope Valves Set (AF series) received FDA 510(k) clearance on 2024-10-01, under 510(k) number K241285.

Who is the listed applicant for Disposable Endoscope Valves Set (AF series)?

The FDA 510(k) record lists Alton (Shanghai) Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscope Valves Set (AF series)?

The FDA product code for Disposable Endoscope Valves Set (AF series) is ODC.

Other records listing Alton (Shanghai) Medical Instruments 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.

K243039Ureteral Stents (AF-D series)K242635Endoscopic Distal Attachment (AF-D series)K241679Disposable Cytology Brush (AF series)K231633Disposable Hemoclip (AF series)K230925Disposable Injection Needle AF series

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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