TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED— 510(k) K131543

Substantially Equivalent

Procter & Gamble Co.

FDA 510(k) clearance K131543 for TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED, Substantially Equivalent on 2013-06-20. Applicant: Procter & Gamble Co..

Clearance details

Applicant: Procter & Gamble Co.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2013-05-29
Decision date: 2013-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, 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.