DeviceClearance

NavaClick Injection System— 510(k) K231877

Substantially Equivalent

Lineage Biomedical, Inc.

FDA 510(k) clearance K231877 for NavaClick Injection System, Substantially Equivalent on 2023-11-30. Applicant: Lineage Biomedical, Inc.. Device class: 2.

Clearance details

Applicant
Lineage Biomedical, Inc.
Product code
Code FMF
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stuart, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FMF

view all

Adverse events under product code FMF

product code FMF
Death
15
Injury
2,263
Malfunction
29,722
Other
17
Total
32,017

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 →

Recalls naming K231877

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K231877.

Data sourced from openFDA. This site is unofficial and independent of the FDA.