Youjia Unscented Tampon with Plastic Applicators— 510(k) K192557

Substantially Equivalent

Qingdao Youjia Hygiene Technology Co., Ltd.

FDA 510(k) clearance K192557 for Youjia Unscented Tampon with Plastic Applicators, Substantially Equivalent on 2020-02-13. Applicant: Qingdao Youjia Hygiene Technology Co., Ltd..

Clearance details

Applicant: Qingdao Youjia Hygiene Technology Co., Ltd.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2019-09-17
Decision date: 2020-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Qingdao, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

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.