FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NovaGuard SA Pro Safety System
K Number: K163511
·
Decision Feb 2, 2017
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
6
Review Days
49
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Basic Information
- Device Name
- NovaGuard SA Pro Safety System
- K Number
- K163511
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- West Pharmaceutical Services, Inc.
- Date Received
- December 15, 2016
- Decision Date
- February 2, 2017
- 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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Other Clearances by West Pharmaceutical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | May 3, 2024 | Substantially Equivalent |
| K151777 | Intradermal Adapter | Sep 29, 2015 | Substantially Equivalent |
| K123588 | INTRADERMAL ADAPTER | Feb 19, 2013 | Substantially Equivalent |
| K082908 | NOVAGUARD, MODEL 3611001 | Apr 24, 2009 | Substantially Equivalent |
| K041691 | CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT | Aug 5, 2004 | Substantially Equivalent |