K922420

Substantially Equivalent

CONTINUOUS FLOW HYSTERO-RESECTOSCOPE

Applicant: Linvatec Corp.
Product code: HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1992-05-21
Decision date: 1994-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, 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.