510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191666Substantially Equivalent

Unscented W long plastic and cardboard applicator tampons

Ontex Bvba, Buggenhout Oost - Vlaanderen, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191666 is the FDA 510(k) clearance record for Unscented W long plastic and cardboard applicator tampons, a class II device, cleared for Ontex Bvba on under FDA product code HEB (Tampon, Menstrual, Unscented). FDA's definition for product code HEB reads: "An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge". FDA records list 6 510(k) clearances for Ontex Bvba, from to . As of , FDA records show no recalls naming K191666.

Clearance record

Decision date
Received
(182 days to decision)
Product code
HEB Tampon, Menstrual, Unscented
Regulation
21 CFR 884.5470
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ontex Bvba 5 Genthof, Buggenhout Oost - Vlaanderen, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HEB

Trailing 12 months
2 clearances under product code HEB in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HEB, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260