510(k) K991563— CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C

Substantially Equivalent

Henke Sass Wolf of America, Inc.

Clearance details

Applicant: Henke Sass Wolf of America, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1999-05-05
Decision date: 1999-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duxbury, MA, US

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.