FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Automatically Retractable Safety Syringes (with detachable needle)
K Number: K222452
·
Decision Nov 23, 2022
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
6
Review Days
100
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Basic Information
- Device Name
- Disposable Automatically Retractable Safety Syringes (with detachable needle)
- K Number
- K222452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
- Date Received
- August 15, 2022
- Decision Date
- November 23, 2022
- Product Code
- MEG
- 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 |
|---|---|---|---|
| MEG | Syringe, Antistick | FDA class 2 | General Hospital |
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Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Shantou Wealy Medical Instrument Co.,Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K210216 | Disposable Automatically Retractable Insulin Safety Syringe | Mar 4, 2022 | Substantially Equivalent |
| K203613 | ENFit Reusable Enteral Syringe | Aug 27, 2021 | Substantially Equivalent |
| K203410 | ENFit Disposable Enteral Syringe | Jun 28, 2021 | Substantially Equivalent |
| K141640 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE | Nov 19, 2014 | Substantially Equivalent |
| K113587 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) | Feb 24, 2012 | Substantially Equivalent |