Interlude Rolled Tampons in Plastic Applicator— 510(k) K191431

Name: FDA 510(k) clearance K191431
Creator: U.S. Food and Drug Administration
Published: 2019-10-07

Substantially Equivalent

Albaad Fem

FDA 510(k) clearance K191431 for Interlude Rolled Tampons in Plastic Applicator, Substantially Equivalent on 2019-10-07. Applicant: Albaad Fem. Device class: 2.

Clearance details

Applicant: Albaad Fem
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 2019-05-29
Decision date: 2019-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea Ind. Park, IL

Download summary PDF View on FDA.gov ↗

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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.