DeviceClearance

TruDi® Navigation System V3 (FG-2000-00)— 510(k) K231862

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K231862 for TruDi® Navigation System V3 (FG-2000-00), Substantially Equivalent on 2023-07-21. Applicant: Acclarent, Inc.. Device class: 2.

Clearance details

Applicant
Acclarent, Inc.
Product code
Code PGW
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PGW

product code PGW
Malfunction
1,199
Total
1,199

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 K231862

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 K231862.

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