BIPOLAR ELECTROSURGICAL SNARE— 510(k) K893553

Substantially Equivalent

Everest Medical Corp.

FDA 510(k) clearance K893553 for BIPOLAR ELECTROSURGICAL SNARE, Substantially Equivalent on 1989-09-08. Applicant: Everest Medical Corp..

Clearance details

Applicant: Everest Medical Corp.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 1989-05-08
Decision date: 1989-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Center, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.