FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Sterile Hypodermic Needles for Single Use
K Number: K223334
·
Decision Dec 16, 2022
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
45
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Basic Information
- Device Name
- Sterile Hypodermic Needles for Single Use
- K Number
- K223334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhejiang Kindly Medical Devices Co., Ltd.
- Date Received
- November 1, 2022
- Decision Date
- December 16, 2022
- 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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Other Clearances by Zhejiang Kindly Medical Devices Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K213183 | Safety Insulin Pen Needles | Oct 14, 2022 | Substantially Equivalent |
| K181069 | Disposable Insulin Pen Needle | Aug 28, 2018 | Substantially Equivalent |
| K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | Jun 4, 2018 | Substantially Equivalent |
| K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | Jan 5, 2018 | Substantially Equivalent |