Cohitech Reusable Tampon Applicator— 510(k) K212479

Substantially Equivalent

Cotton High Tech S.L.

FDA 510(k) clearance K212479 for Cohitech Reusable Tampon Applicator, Substantially Equivalent on 2021-10-08. Applicant: Cotton High Tech S.L..

Clearance details

Applicant: Cotton High Tech S.L.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2021-08-09
Decision date: 2021-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Balsareny, ES

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.