510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Yangzhou Fartley Medical Instrument Technology Co., Ltd

Yangzhou Jiangsu, CN

YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD appears in FDA device records in Yangzhou Jiangsu, CN. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 8 510(k) clearances for Yangzhou Fartley Medical Instrument Technology Co., Ltd between 2022 and 2026. The busiest year on record is 2022, with 5. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Yangzhou Fartley Medical Instrument Technology Co., Ltd, by decision year
YearClearances
20225
20231
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260423Disposable Endoscopic Distal AttachmentsFDFSubstantially Equivalent
K250732Disposable Endoscopy Valve SetODCSubstantially Equivalent
K230004Disposable HemoclipPKLSubstantially Equivalent
K222980Pentax Medical Valve SetODCSubstantially Equivalent
K220785Clean Connecting TubeOCXSubstantially Equivalent
K220292Disposable Endoscope Injection NeedleFBKSubstantially Equivalent
K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareFDISubstantially Equivalent
K220210Disposable Endoscopy Adapter SetODCSubstantially Equivalent

Registered establishments

FDA registered establishments for Yangzhou Fartley Medical Instrument Technology Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30111934033011193403YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTDBeizhou Road, Lidian Town, Guangling District, Yangzhou Jiangsu 225106 CN2026and 13 more, listed in full below
30357861583035786158Yangzhou Fartley Medical Instrument Technology Co., LtdNo. 7 Youkang Road, Touqiao Town, Guangling District, Yangzhou Jiangsu 225000 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain