Unscented Menstrual Tampon— 510(k) K222046

Substantially Equivalent

Suzhou Borage Medical Technology Co., Ltd.

FDA 510(k) clearance K222046 for Unscented Menstrual Tampon, Substantially Equivalent on 2022-09-30. Applicant: Suzhou Borage Medical Technology Co., Ltd..

Clearance details

Applicant: Suzhou Borage Medical Technology Co., Ltd.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2022-07-11
Decision date: 2022-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, 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.