re.t.a Reuseable Tampon Applicator— 510(k) K180850

Substantially Equivalent

Thinx, Inc.

FDA 510(k) clearance K180850 for re.t.a Reuseable Tampon Applicator, Substantially Equivalent on 2018-08-20. Applicant: Thinx, Inc..

Clearance details

Applicant: Thinx, Inc.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2018-04-02
Decision date: 2018-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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.