OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL— 510(k) K053583

Substantially Equivalent

Optivia Medical, LLC

FDA 510(k) clearance K053583 for OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL, Substantially Equivalent on 2006-03-31. Applicant: Optivia Medical, LLC.

Clearance details

Applicant: Optivia Medical, LLC
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2005-12-23
Decision date: 2006-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, 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.