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

Barrier, Std, Oral Sex

21 CFR 884.5300 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

MSC is the FDA product code for Barrier, Std, Oral Sex, a class II device type, regulated under 21 CFR 884.5300. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MSC
Device name
Barrier, Std, Oral Sex
Regulation
21 CFR 884.5300
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
7
Ingested recalls
0

Clearances, product code MSC

By decision year
7 clearances under product code MSC with a decision year between 1998 and 2026, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MSC by decision year
YearClearances
19981
19991
20101
20211
20222
20261

Applicants with the most clearances

Product code MSC
Applicants holding the most 510(k) clearances under product code MSC
ApplicantClearances
Brazen Goods Inc. dba Lorals1
Glyde USA, Inc.1
Line One Laboratories1
Louise C. Myers1
Luwi, LLC1
Pamco Distributing, Inc.1
Sanctuary Health Sdn Bhd1

Companies listing this code with FDA

Companies whose registered establishments list this code