Cleared Traditional

Filter Needle for Single Use

K233277 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · General Hospital
May 2024
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K233277 is an FDA 510(k) clearance for the Filter Needle for Single Use, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 10, 2024, 224 days after receiving the submission on September 29, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K233277 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date May 10, 2024
Days to Decision 224 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPB — Filter, Infusion Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440