Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Endoscopy Adapter Set

K-Number: K220210 · 2022-06-17

ApplicantYangzhou Fartley Medical Instrument Technology Co., Ltd.
Decision Date2022-06-17
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopy Adapter Set 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 2022-06-17 under 510(k) number K220210. 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 Endoscopy Adapter Set?

Disposable Endoscopy Adapter Set is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K220210.

When did Disposable Endoscopy Adapter Set receive FDA 510(k) clearance?

Disposable Endoscopy Adapter Set received FDA 510(k) clearance on 2022-06-17, under 510(k) number K220210.

Who is the listed applicant for Disposable Endoscopy Adapter Set?

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 Endoscopy Adapter Set?

The FDA product code for Disposable Endoscopy Adapter Set is ODC.

Other records listing Yangzhou Fartley Medical Instrument Technology 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.

K260423Disposable Endoscopic Distal AttachmentsK250732Disposable Endoscopy Valve SetK230004Disposable HemoclipK222980Pentax Medical Valve SetK220785Clean Connecting TubeK220292Disposable Endoscope Injection Needle

View all 8 devices →

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.

↑