FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
LDV((Low Dead Volume )Syringe
K Number: K220083
·
Decision May 25, 2022
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
11
Applicant Total
12
Review Days
135
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Basic Information
- Device Name
- LDV((Low Dead Volume )Syringe
- K Number
- K220083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Date Received
- January 10, 2022
- Decision Date
- May 25, 2022
- Product Code
- QNQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QNQ | Low Dead Space Piston Syringe | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QNQ), ordered by most recent decision date.
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
FDA 510(k)
FDA Class 2
·General Hospital
TSK Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Small Volume 0.2mL Syringe
FDA 510(k)
FDA Class 2
·General Hospital
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
FDA 510(k)
FDA Class 2
·General Hospital
Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
FDA 510(k)
FDA Class 2
·General Hospital
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K234024 | HWJECT Auto-disable syringe | Mar 19, 2024 | Substantially Equivalent |
| K230061 | Insulin Syringe | Nov 30, 2023 | Substantially Equivalent |
| K230043 | Insulin Pen Needle | Sep 20, 2023 | Substantially Equivalent |
| K223323 | Blood Collection Needle (with/without Needle Holder) | Mar 24, 2023 | Substantially Equivalent |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | Nov 4, 2022 | Substantially Equivalent |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | Oct 21, 2022 | Substantially Equivalent |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | Aug 10, 2022 | Substantially Equivalent |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) | Apr 12, 2022 | Substantially Equivalent |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | Oct 18, 2021 | Substantially Equivalent |
| K202188 | Safety Blood Collection Sets for Single Use | Feb 19, 2021 | Substantially Equivalent |