I-PORT ADVANCE INJECTION PORT— 510(k) K120337
Substantially EquivalentUnomedical A/S
FDA 510(k) clearance K120337 for I-PORT ADVANCE INJECTION PORT, Substantially Equivalent on 2012-02-16. Applicant: Unomedical A/S. Device class: 2.
Clearance details
- Applicant
- Unomedical A/S
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Osted, DK
Recent devices under product code FOZ
view allMore clearances from Unomedical A/S
view all- K210544 — Medtronic Extended infusion set
- K192647 — neria guard Infusion Set
- K173879 — MiniMed Mio Advance infusion set
- K162812 — 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
- K160648 — MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.