← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

KGN — Wound Dressing With Animal-Derived Material(S)

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
25
510(K)/PMA CLEARANCES
510k: 25
0
RECALL ENTRIES

Recent clearances

K260596Ventris Medical · 510k2026-07-02
K260669Aroa Biosurgery , Ltd. · 510k2026-06-24
K253521Ecm Therapeutics, Inc. · 510k2026-06-18
K253204BioTissue Holdings, Inc. · 510k2026-06-05
K254034Roosin Medical Co., Ltd. · 510k2026-06-03
K253974Roosin Medical Co., Ltd. · 510k2026-06-03
K261224Medskin Solutions Dr. Suwelack AG · 510k2026-05-14
K260532Geistlich Pharma AG · 510k2026-03-19

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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