FEELject LDV (Low dead volume) syringe
FDA 510(k) K213010 · Feeltech Co., Ltd.
510(k) numberK213010
Submission
- Device name
- FEELject LDV (Low dead volume) syringe
- Applicant
- Feeltech Co., Ltd.
Gunsan-Si, KR - Received
- September 20, 2021
- Decision date
- May 31, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNQ – Low Dead Space Piston Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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.
Other 510(k)s with product code QNQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252814 | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead…QNQ · Traditional | CMT Health PTE., Ltd. | 02/19/2026SE |
| K250127 | TSK SyringeQNQ · Traditional | Tsk Laboratory, Japan | 07/30/2025SE |
| K250138 | Small Volume 0.2mL SyringeQNQ · Traditional | Prosum Medical Limited | 04/02/2025SE |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…QNQ · Traditional | Sol-Millennium Medical, Inc. | 11/20/2024SE |
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space SyringeQNQ · Traditional | Smiths Medical Asd, Inc. | 05/31/2024SE |
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume)…QNQ · Special | Poonglim Pharmatech, Inc. | 05/29/2024SE |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))QNQ · Traditional | Medexel Co.,Ltd | 03/15/2024SE |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume)…QNQ · Traditional | Poonglim Pharmatech, Inc. | 09/15/2023SE |
| K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeQNQ · Traditional | Jeil Tech Co., Ltd. | 09/19/2022SE |
| K220083 | LDV((Low Dead Volume )SyringeQNQ · Traditional | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 05/25/2022SE |
More from Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Questions and answers
When was FEELject LDV (Low dead volume) syringe cleared by the FDA?
FEELject LDV (Low dead volume) syringe (K213010) received a 510(k) decision of Substantially Equivalent on May 31, 2023, 618 days after the submission was received.
What is the product code of K213010?
The FDA product code is QNQ – Low Dead Space Piston Syringe, a Class II (moderate risk) device regulated under 21 CFR 880.5860.