DeviceClearance

Product code PHN— Unknown

PuraStat

Classification name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device class
Unclassified
Advisory panel
Unknown
Total cleared
5
First cleared
Most recent

FDA classification definition

“Mucoadhesive application for the protective coating of the rectal mucosa.”

— U.S. Food and Drug Administration, device classification record for product code PHN, via openFDA

Market context for product code PHN

FDA has cleared 5 devices under product code PHN between 2014 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code.

Clearances per year

Top applicants under product code PHN

Recent clearances under product code PHN

Data sourced from openFDA. This site is unofficial and independent of the FDA.