Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl— 510(k) K161877

Clearance details

Applicant

First Quality Hygienic, Inc.

Product code

Code HEB

Device class

Class 2

Regulation

21 CFR 884.5470

Advisory panel

Obstetrics/Gynecology

Date received

2016-07-08

Decision date

2016-08-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Mcelhattan, PA, US

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• K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS2025-10-09
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• K251033 — Unscented menstrual long applicator tampon +3 more2025-08-13

• K151470 — Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency +3 more2015-11-02
• K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS2005-07-14
• K050660 — FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS2005-05-12
• K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS2005-02-01
• K032173 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS2003-09-03

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 →