nSet+ Stabilization Set [6426733] +2 more— 510(k) K251257
Substantially EquivalentNp Medical
FDA 510(k) clearance K251257 for nSet+ Stabilization Set [6426733] +2 more, Substantially Equivalent on 2025-12-04. Applicant: Np Medical. Device class: 2.
Clearance details
- Device name as filed
- nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
- Applicant
- Np Medical
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clinton, MA, US
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More clearances from Np Medical
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.