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 Europe SAS and 3-D Matrix, Inc..
FDA 510(k) Cleared Protective Coating, Mucoadhesive Application, For The Rectal Mucosa Devices (Product Code PHN)
About Product Code PHN - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PHN since 2014, with 4 receiving FDA clearance (average review time: 110 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PHN have taken an average of 82 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 →