TRU-CORE NEEDLE SET— 510(k) K943368

Name: FDA 510(k) clearance K943368
Creator: U.S. Food and Drug Administration
Published: 1994-07-29

Substantially Equivalent

Ideamatrix

FDA 510(k) clearance K943368 for TRU-CORE NEEDLE SET, Substantially Equivalent on 1994-07-29. Applicant: Ideamatrix. Device class: 2.

Clearance details

Applicant: Ideamatrix
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-13
Decision date: 1994-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Estes Park, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.