NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector— 510(k) K220288

Substantially Equivalent

Np Medical, Inc.

FDA 510(k) clearance K220288 for NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector, Substantially Equivalent on 2023-04-19. Applicant: Np Medical, Inc.. Device class: 2.

Clearance details

Applicant
Np Medical, Inc.
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
Download summary PDFView on FDA.gov ↗

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Adverse 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.