FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
GRI-FILL PERISTALTIC SET
K Number: K162216
·
Decision Oct 19, 2017
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
9
Review Days
437
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Basic Information
- Device Name
- GRI-FILL PERISTALTIC SET
- K Number
- K162216
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laboratorios Grifols, S.A.
- Date Received
- August 8, 2016
- Decision Date
- October 19, 2017
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Laboratorios Grifols, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K102590 | FLEBOSET DOUBLE | Jan 13, 2011 | Substantially Equivalent |
| K093182 | SET GRI-FILL 3.0 | Jan 27, 2010 | Substantially Equivalent |
| K082752 | QUICKPIN | Sep 29, 2008 | Substantially Equivalent |
| K050339 | SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE | Feb 25, 2005 | Substantially Equivalent |
| K040456 | FLEBOSET MULTIPLE | Mar 9, 2004 | Substantially Equivalent |
| K033916 | GRI-BAG, GRI-BAG AP | Dec 30, 2003 | Substantially Equivalent |
| K033682 | SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE | Dec 17, 2003 | Substantially Equivalent |
| K031419 | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML | Nov 24, 2003 | Substantially Equivalent |