FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFEPRO PLUS SAFETY SYRINGE
K Number: K031830
·
Decision Aug 5, 2003
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
3
Review Days
53
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SAFEPRO PLUS SAFETY SYRINGE
- K Number
- K031830
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Formosa Medical Devices, Inc.
- Date Received
- June 13, 2003
- Decision Date
- August 5, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEG), ordered by most recent decision date.
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
FDA 510(k)
FDA Class 2
·General Hospital
VaporShield
FDA 510(k)
FDA Class 2
·General Hospital
SaviSafe Safety Device
FDA 510(k)
FDA Class 2
·General Hospital
Shina Syringe; Shina Safety Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Medline Safety Insulin and TB Syringes
FDA 510(k)
FDA Class 2
·General Hospital
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