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FDA PRODUCT CODE · UNCLASSIFIED

PHN — Protective Coating, Mucoadhesive Application, For The Rectal Mucosa

Mucoadhesive application for the protective coating of the rectal mucosa.

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K2539233-D Matrix Europe SAS · 510k2026-01-07
K2426343-D Matrix Europe SAS · 510k2025-01-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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