TruClear Elite Hysteroscope— 510(k) K180496

Substantially Equivalent

Covidien

FDA 510(k) clearance K180496 for TruClear Elite Hysteroscope, Substantially Equivalent on 2018-08-29. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2018-02-26
Decision date: 2018-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

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.