FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
K Number: K162812
·
Decision Nov 1, 2017
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
13
Review Days
391
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Basic Information
- Device Name
- Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
- K Number
- K162812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unomedical A/S
- Date Received
- October 6, 2016
- Decision Date
- November 1, 2017
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Unomedical A/S
| K Number | Device Name | ||
|---|---|---|---|
| K210544 | Medtronic Extended infusion set | Jul 16, 2021 | Substantially Equivalent |
| K192647 | neria guard Infusion Set | Dec 13, 2019 | Substantially Equivalent |
| K173879 | MiniMed Mio Advance infusion set | Mar 5, 2018 | Substantially Equivalent |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | Aug 10, 2016 | Substantially Equivalent |
| K132142 | NERIA SOFT 90 INFUSION SET | Oct 8, 2013 | Substantially Equivalent |
| K120337 | I-PORT ADVANCE INJECTION PORT | Feb 16, 2012 | Substantially Equivalent |
| K070430 | PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS | Apr 4, 2007 | Substantially Equivalent |
| K061374 | INTUITION INFUSION SETS | Jul 31, 2006 | Substantially Equivalent |
| K051264 | COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS | Sep 1, 2005 | Substantially Equivalent |
| K041545 | CONTACT DETACH | Jun 30, 2004 | Substantially Equivalent |