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FDA 510(k)

Disposable Endoscopic Distal Attachments

K-Number: K260423 · 2026-05-28

ApplicantYangzhou Fartley Medical Instrument Technology Co., Ltd.
Decision Date2026-05-28
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopic Distal Attachments is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K260423. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Endoscopic Distal Attachments?

Disposable Endoscopic Distal Attachments is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K260423.

When did Disposable Endoscopic Distal Attachments receive FDA 510(k) clearance?

Disposable Endoscopic Distal Attachments received FDA 510(k) clearance on 2026-05-28, under 510(k) number K260423.

Who is the listed applicant for Disposable Endoscopic Distal Attachments?

The FDA 510(k) record lists Yangzhou Fartley Medical Instrument Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Distal Attachments?

The FDA product code for Disposable Endoscopic Distal Attachments is FDF.

Other records listing Yangzhou Fartley Medical Instrument Technology Co., Ltd. as applicant

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Related Devices (Code: FDF)

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.

K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFujifilm CorporationK250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)Olympus 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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