Atlas FDA

Introducer Needle

FDA 510(k) clearance K222705 · decided 2023-05-22

Clearance details

K-number
K222705
Device name
Introducer Needle
Applicant
Youcare Technology Co.,Ltd. (Wuhan)
Decision
Substantially Equivalent
Date received
2022-09-07
Decision date
2023-05-22
Days to decision
257 days
Clearance type
Traditional
Product code
LJE
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Wuhan, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.