FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
TK Sterile Hypodermic Needle
K Number: K191643
·
Decision Dec 19, 2019
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
12
Review Days
183
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Basic Information
- Device Name
- TK Sterile Hypodermic Needle
- K Number
- K191643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anhui Tiankang Medical Technology Co., Ltd.
- Date Received
- June 19, 2019
- Decision Date
- December 19, 2019
- 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 Anhui Tiankang Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K222772 | Oral/Enteral Syringe with ENFit connector | Aug 17, 2023 | Substantially Equivalent |
| K222773 | Feeding Tube | Aug 17, 2023 | Substantially Equivalent |
| K230756 | TK Pre-Filled Normal Saline Flush Syringe | Aug 12, 2023 | Substantially Equivalent |
| K222385 | Bifurcated Needle | Dec 6, 2022 | Substantially Equivalent |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle | Jul 14, 2022 | Substantially Equivalent |
| K212368 | Surgical Face Mask | Oct 24, 2021 | Substantially Equivalent |
| K210464 | Auto Disable Syringe | Aug 24, 2021 | Substantially Equivalent |
| K191639 | TK Insulin Syringe with/without Saftey Retractable Device | Sep 11, 2020 | Substantially Equivalent |
| K191640 | TK Intravascular Administration Set | Aug 26, 2020 | Substantially Equivalent |
| K191644 | TK Safety Needle | Aug 6, 2020 | Substantially Equivalent |