FDA Product Code PHN: Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa.
Leading manufacturers include 3-D Matrix, Inc., 3-D Matrix Europe SAS and Access Pharmaceuticals, Inc..
5
Total
5
Cleared
106d
Avg days
2014
Since
Growing category -
3 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
84d
recently vs 139d historically
FDA 510(k) Cleared Protective Coating, Mucoadhesive Application, For The Rectal Mucosa Devices (Product Code PHN)
5 devices
Cleared
Aug 03, 2026
PuraStat-RM
3-D Matrix, Inc.
Gastroenterology & Urology
89d
Cleared
Jan 07, 2026
PuraStat
3-D Matrix Europe SAS
Gastroenterology & Urology
30d
Cleared
Jan 15, 2025
PuraStat
3-D Matrix Europe SAS
Gastroenterology & Urology
134d
Cleared
Apr 01, 2022
PuraStat-RM
3-D Matrix, Inc.
Gastroenterology & Urology
144d
Cleared
Jul 16, 2014
PROCTIGARD
Access Pharmaceuticals, Inc.
Gastroenterology & Urology
133d
About Product Code PHN - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code PHN since 2014, with 5 receiving FDA clearance (average review time: 106 days).
Submission volume has increased in recent years - 3 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 - PHN Product Code
Recent submissions under PHN have taken an average of 84 days to reach a decision - down from 139 days historically, suggesting improved FDA processing for this classification.
PHN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →