FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing— 510(k) K252015
Substantially EquivalentKoru Medical Systems, Inc.
FDA 510(k) clearance K252015 for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing, Substantially Equivalent on 2026-01-28. Applicant: Koru Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Koru Medical Systems, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
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Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.