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

Weihai Shandong, CN

ShanDong WeiGao Group Medical Polymer Co., Ltd appears in FDA device records in Weihai Shandong, CN. FDA records list 7 510(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
7
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for ShanDong WeiGao Group Medical Polymer Co., Ltd between 2007 and 2023. The busiest year on record is 2008, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for ShanDong WeiGao Group Medical Polymer Co., Ltd, by decision year
YearClearances
20071
20082
20112
20221
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K212207Sterile Hypodermic Syringe for Single UseFMFSubstantially Equivalent
K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single UseFMFSubstantially Equivalent
K102741ENTERAL FEEDING BAG AND SETSKNTSubstantially Equivalent
K102328BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULAFMISubstantially Equivalent
K081241WEIGAO EMPTY CARTRIDGE SYRINGEFMFSubstantially Equivalent
K072739JIERUI SYRINGES AND NEEDLESMEGSubstantially Equivalent
K073127BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22GFMISubstantially Equivalent

Registered establishments

FDA registered establishments for ShanDong WeiGao Group Medical Polymer Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30070845753007084575ShanDong WeiGao Group Medical Polymer Co., LtdNo.1 Weigao Road, Torch Hi-tech Science Park, Weihai Shandong 264210 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

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