FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
K Number: K031062
·
Decision May 2, 2003
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
163
Applicant Total
4
Review Days
29
Basic Information
- Device Name
- TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
- K Number
- K031062
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TAIJECT MEDICAL DEVICE CO., LTD.
- Date Received
- April 3, 2003
- Decision Date
- May 2, 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.
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
PowerPAK Syringe
FDA 510(k)
FDA Class 2
·General Hospital
SafeR Syringe and SafeR Sting
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by TAIJECT MEDICAL DEVICE CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K042426 | TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN) | Sep 22, 2004 | Substantially Equivalent |
| K023458 | TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML) | Nov 7, 2002 | Substantially Equivalent |
| K022278 | TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML) | Sep 12, 2002 | Substantially Equivalent |