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

Protective Coating, Mucoadhesive Application, For The Rectal Mucosa

Unknown
FDA source (opens on fda.gov)

PHN is the FDA product code for Protective Coating, Mucoadhesive Application, For The Rectal Mucosa. FDA's definition for this code reads: "Mucoadhesive application for the protective coating of the rectal mucosa". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PHN
Device name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
FDA definition
Mucoadhesive application for the protective coating of the rectal mucosa.
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code PHN

By decision year
5 clearances under product code PHN with a decision year between 2014 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PHN by decision year
YearClearances
20141
20221
20251
20262

Applicants with the most clearances

Product code PHN
Applicants holding the most 510(k) clearances under product code PHN
ApplicantClearances
3-D Matrix Europe SAS2
3-D Matrix, Inc.2
Access Pharmaceuticals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code