PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520— 510(k) K093399

Name: FDA 510(k) clearance K093399
Creator: U.S. Food and Drug Administration
Published: 2009-11-19

Substantially Equivalent

Inrad

FDA 510(k) clearance K093399 for PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520, Substantially Equivalent on 2009-11-19. Applicant: Inrad. Device class: 2.

Clearance details

Applicant: Inrad
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2009-11-02
Decision date: 2009-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kentwood, MI, 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.