Cleared Traditional

Single Use Injection Needle

K210917 · Anrei Medical (Hangzhou) Co., Ltd. · Gastroenterology & Urology

May 2021

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K210917 is an FDA 510(k) clearance for the Single Use Injection Needle, a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by Anrei Medical (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 28, 2021, 60 days after receiving the submission on March 29, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K210917 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2021
Decision Date	May 28, 2021
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FBK — Endoscopic Injection Needle, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.