FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Pen Needle
K Number: K230635
·
Decision Jun 2, 2023
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
15
Review Days
87
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Basic Information
- Device Name
- Pen Needle
- K Number
- K230635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jiangsu Caina Medical Co.,Ltd
- Date Received
- March 7, 2023
- Decision Date
- June 2, 2023
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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| K211593 | Enteral Pump Syringe | Sep 30, 2021 | Substantially Equivalent |
| K210217 | Needleless Connector | May 17, 2021 | Substantially Equivalent |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Apr 7, 2021 | Substantially Equivalent |
| K201356 | Plastic LOR Syringe | Feb 12, 2021 | Substantially Equivalent |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter | Sep 9, 2020 | Substantially Equivalent |
| K193022 | Retractable Safety Insulin Syringe | Jul 20, 2020 | Substantially Equivalent |
| K193526 | Syringe with safety needle, Safety needle | Jul 17, 2020 | Substantially Equivalent |