Cleared Traditional

FEELject LDV (Low dead volume) syringe

K213010 · Feeltech Co., Ltd. · General Hospital

May 2023

Decision

618d

Days

Class 2

Risk

About This 510(k) Submission

K213010 is an FDA 510(k) clearance for the FEELject LDV (Low dead volume) syringe, a Low Dead Space Piston Syringe (Class II — Special Controls, product code QNQ), submitted by Feeltech Co., Ltd. (Gunsan-Si, KR). The FDA issued a Cleared decision on May 31, 2023, 618 days after receiving the submission on September 20, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K213010 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2021
Decision Date	May 31, 2023
Days to Decision	618 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	QNQ — Low Dead Space Piston Syringe
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5860
Definition	A Low Dead Space Syringe Is A Piston Syringe Designed To Reduce Medication Waste. The Device Consists Of A Calibrated Hollow Barrel, A Moveable Plunger, And May Include A Needle. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient.