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

Hangzhou Zhejiang, CN

ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. 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
13
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 13 510(k) clearances for Zhejiang Chuangxiang Medical Technology Co., Ltd. between 2018 and 2026. The busiest year on record is 2022, with 4. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Zhejiang Chuangxiang Medical Technology Co., Ltd., by decision year
YearClearances
20183
20191
20201
20224
20232
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253132Single use stone retrieval balloonsFGESubstantially Equivalent
K251890Disposable Ureteral StentsFADSubstantially Equivalent
K230773Endoscopy Irrigation TubingOCXSubstantially Equivalent
K231471Air/Water Bottle Tubing, CO2 Source TubingOCXSubstantially Equivalent
K220063Single Use Cytology BrushFDXSubstantially Equivalent
K212669Single Use HemoclipPKLSubstantially Equivalent
K220065Single Use Ureteral Access SheathFEDSubstantially Equivalent
K212668Sclerotherapy NeedleFBKSubstantially Equivalent
K191900Single Use Grasping ForcepsOCZSubstantially Equivalent
K192258Disposable Valve SetsODCSubstantially Equivalent
K173758Disposable Biopsy ValveOCXSubstantially Equivalent
K172762Single Use HemoclipPKLSubstantially Equivalent
K172758Rotatable Snares, Non-Rotatable SnaresFDISubstantially Equivalent

Registered establishments

FDA registered establishments for Zhejiang Chuangxiang Medical Technology Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30134607193013460719ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.Room 101-1, 201-1, 301, 401, Building 50, No.650 Hongfeng Road, Donghu Street, Linping District, Hangzhou Zhejiang 311100 CN2026and 17 more, listed in full below

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

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