510(k) K220083
- Device
- LDV((Low Dead Volume )Syringe
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- 510(k) number
- K220083
- Product code
- QNQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-05-25
- Date received
- 2022-01-10
- Regulation
- 880.5860
- Classification name
- Low Dead Space Piston Syringe
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bingyi Xiang
- Address
- #2 Guanyin Rd., Taihu Economic Development Zone Anqing CN 246400 246400
FDA Registration Numbers#
- 3038294399
- 3005405146
- 3014312726
- 3038356900
- 3010462274
- 9615588
- 3029905131
- 3007774504
- 3012116434
- 3012552122
- 3012478173
- 3008719222
- 3036722184
Source Documents#
Other 510(k) Records For Product Code QNQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe | CMT Health PTE., Ltd. | 2026-02-19 |
| K250127 | TSK Syringe | Tsk Laboratory, Japan | 2025-07-30 |
| K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | 2025-04-02 |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle | Sol-Millennium Medical, Inc. | 2024-11-20 |
| K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. | 2024-05-31 |
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. | 2024-05-29 |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | 2024-03-15 |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. | 2023-09-15 |
| K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | 2023-05-31 |
| K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe | Jeil Tech Co., Ltd. | 2022-09-19 |
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021-02-16 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases