Spectra 9Plus— 510(k) K162415

Substantially Equivalent

Uzinmedicare Company

FDA 510(k) clearance K162415 for Spectra 9Plus, Substantially Equivalent on 2017-03-15. Applicant: Uzinmedicare Company.

Clearance details

Applicant: Uzinmedicare Company
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2016-08-29
Decision date: 2017-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.