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FDA 510(k)

Endoscopic Distal Attachment (AF-D series)

K-Number: K242635 · 2025-05-30

ApplicantAlton (Shanghai) Medical Instruments Co., Ltd.
Decision Date2025-05-30
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Distal Attachment (AF-D series) is a medical device manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-05-30 under approval number K242635. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscopic Distal Attachment (AF-D series)?

Endoscopic Distal Attachment (AF-D series) is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K242635.

When was Endoscopic Distal Attachment (AF-D series) approved by the FDA?

Endoscopic Distal Attachment (AF-D series) received FDA 510(k) clearance on 2025-05-30, under approval number K242635.

What company makes Endoscopic Distal Attachment (AF-D series)?

Endoscopic Distal Attachment (AF-D series) is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd..

What is the FDA product code for Endoscopic Distal Attachment (AF-D series)?

The FDA product code for Endoscopic Distal Attachment (AF-D series) is FDS.

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Other Devices by Alton (Shanghai) Medical Instruments Co., Ltd.

K230925Disposable Injection Needle AF series K241285Disposable Endoscope Valves Set (AF series) K231633Disposable Hemoclip (AF series) K243039Ureteral Stents (AF-D series) K241679Disposable Cytology Brush (AF series)

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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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