Organic cotton tampon, Viscose tampon— 510(k) K231341

Substantially Equivalent

Zhejiang Tianqing Manufacturing Technology Group Co., Ltd.

FDA 510(k) clearance K231341 for Organic cotton tampon, Viscose tampon, Substantially Equivalent on 2023-08-14. Applicant: Zhejiang Tianqing Manufacturing Technology Group Co., Ltd..

Clearance details

Applicant: Zhejiang Tianqing Manufacturing Technology Group Co., Ltd.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2023-05-09
Decision date: 2023-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huzhou, 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.