FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Insulin Syringe
K Number: K230061
·
Decision Nov 30, 2023
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
12
Review Days
325
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Basic Information
- Device Name
- Insulin Syringe
- K Number
- K230061
- 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 9, 2023
- Decision Date
- November 30, 2023
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K234024 | HWJECT Auto-disable syringe | Mar 19, 2024 | 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 |
| K220083 | LDV((Low Dead Volume )Syringe | May 25, 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 |