MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-— 510(k) K111529

Substantially Equivalent

Insert Molding Solutions, Inc.

FDA 510(k) clearance K111529 for MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-, Substantially Equivalent on 2011-07-29. Applicant: Insert Molding Solutions, Inc..

Clearance details

Applicant: Insert Molding Solutions, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-02
Decision date: 2011-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumming, GA, US

Download summary PDF View on FDA.gov ↗

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.