FDA Product Code MSC: Barrier, Std, Oral Sex
Leading manufacturers include Pamco Distributing, Inc., Sanctuary Health Sdn. Bhd. and Brazen Goods Inc. Dba Lorals.
7
Total
7
Cleared
223d
Avg days
1998
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
236d avg (recent)
FDA 510(k) Cleared Barrier, Std, Oral Sex Devices (Product Code MSC)
7 devices
Cleared
Apr 22, 2022
Lorals
Brazen Goods Inc. Dba Lorals
Obstetrics & Gynecology
220d
Cleared
Mar 28, 2022
SancDam Latex Oral Dam
Sanctuary Health Sdn. Bhd.
Obstetrics & Gynecology
271d
Cleared
Aug 05, 2021
Harmony Latex Dam, Harmony Non-Latex Dam
Pamco Distributing, Inc.
Obstetrics & Gynecology
227d
About Product Code MSC - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code MSC since 1998, with 7 receiving FDA clearance (average review time: 223 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MSC Product Code
FDA review times for MSC submissions have been consistent, averaging 236 days recently vs 220 days historically.
MSC devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →