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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 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 2025-05-30 under 510(k) 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. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K242635.

When did Endoscopic Distal Attachment (AF-D series) receive FDA 510(k) clearance?

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

Who is the listed applicant for Endoscopic Distal Attachment (AF-D 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 Endoscopic Distal Attachment (AF-D series)?

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

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

Related Devices (Code: FDS)

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.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm CorporationK253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm CorporationK251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.

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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