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

Tampon, Menstrual, Scented, Scented-Deodorized

21 CFR 884.5460 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HIL is the FDA product code for Tampon, Menstrual, Scented, Scented-Deodorized, a class II device type, regulated under 21 CFR 884.5460. FDA's definition for this code reads: "A scented or scented-deodorized 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". As of , FDA records hold 84 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HIL
Device name
Tampon, Menstrual, Scented, Scented-Deodorized
FDA definition
A scented or scented-deodorized 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.
Regulation
21 CFR 884.5460
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
84
Ingested recalls
0

Clearances, product code HIL

By decision year
84 clearances under product code HIL with a decision year between 1976 and 2014, 1987 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code HIL by decision year
YearClearances
19763
19771
19782
19802
19818
19831
19843
19851
19862
19879
19886
19894
19912
19921
19932
19948
19953
19963
19971
19981
20012
20024
20032
20042
20052
20061
20072
20082
20122
20131
20141

Applicants with the most clearances

Product code HIL
Applicants holding the most 510(k) clearances under product code HIL
ApplicantClearances
Playtex Family Products, Inc.15
Playtex, Inc.13
Tambrands Inc.13
Playtex Products, Inc.11
Personal Products Co.6
Intl. Playtex, Inc.5
Procter & Gamble Co.4
Procter & Gamble Mfg. Co.4
First Quality Hygienic, Inc.3
Playtime Products, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order