FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
K Number: K161606
·
Decision Feb 10, 2017
Classifications
1
FEI Numbers
553
Registration Numbers
553
Same Product Code
738
Applicant Total
22
Review Days
245
Basic Information
- Device Name
- Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
- K Number
- K161606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TERUMO EUROPE N.V.
- Date Received
- June 10, 2016
- Decision Date
- February 10, 2017
- 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 |
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Other Clearances by TERUMO EUROPE N.V.
| K Number | Device Name | ||
|---|---|---|---|
| K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | Jun 25, 2015 | Substantially Equivalent |
| K150263 | K-Pack II Needle-21G x 2 | Apr 1, 2015 | Substantially Equivalent |
| K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) | Mar 18, 2014 | Substantially Equivalent |
| K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | Feb 5, 2014 | Substantially Equivalent |
| K132233 | K-PACK II NEEDLE - 27G X 3/4 THIN WALL | Sep 6, 2013 | Substantially Equivalent |
| K111797 | 27 G X 1/2 K-PACK SURSHIELD NEEDLE | Sep 22, 2011 | Substantially Equivalent |
| K110850 | K-PACK II NEEDLE- 27G & 30G THIN WALL | Jun 9, 2011 | Substantially Equivalent |
| K110527 | K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE | Jun 6, 2011 | Substantially Equivalent |
| K100946 | INTRAVSCULAR ADMINISTRATION SET | Aug 2, 2010 | Substantially Equivalent |
| K083514 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | May 22, 2009 | Substantially Equivalent |