FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sterile syringes for single use with/without needle
K Number: K211211
·
Decision Oct 7, 2021
Classifications
1
FEI Numbers
553
Registration Numbers
553
Same Product Code
738
Applicant Total
4
Review Days
167
Basic Information
- Device Name
- Sterile syringes for single use with/without needle
- K Number
- K211211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Azur Medical Company Inc.
- Date Received
- April 23, 2021
- Decision Date
- October 7, 2021
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMF), ordered by most recent decision date.
3DOSE 1ml Syringe
FDA 510(k)
FDA Class 2
·General Hospital
GPS Advanced; GPS Advanced Cannula
FDA 510(k)
FDA Class 2
·General Hospital
GO-PEN®
FDA 510(k)
FDA Class 2
·General Hospital
GraftGun Universal Graft Delivery System (GDS)
FDA 510(k)
FDA Class 2
·General Hospital
Insulin Syringes
FDA 510(k)
FDA Class 2
·General Hospital
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
FDA 510(k)
FDA Class 2
·General Hospital