MODIFICATION TO EN-BLOC BIOPSY SYSTEM— 510(k) K033427

Substantially Equivalent

Neothermia Corp.

FDA 510(k) clearance K033427 for MODIFICATION TO EN-BLOC BIOPSY SYSTEM, Substantially Equivalent on 2003-11-10. Applicant: Neothermia Corp..

Clearance details

Applicant: Neothermia Corp.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2003-10-28
Decision date: 2003-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick, MA, 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.