510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K191992Substantially Equivalent

PELNAC Bilayer Wound Matrix

Gunze Limited, Ayabe, Kyoto, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191992 is the FDA 510(k) clearance record for PELNAC Bilayer Wound Matrix, cleared for Gunze Limited on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list 5 510(k) clearances for Gunze Limited, from to . As of , FDA records show no recalls naming K191992.

Clearance record

Decision date
Received
(279 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Gunze Limited 46 Natsumegaichi, Aono, Ayabe, Kyoto, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGN

Trailing 12 months
16 clearances under product code KGN in the twelve months to October 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code KGN, trailing twelve months
MonthClearances
November 20250
December 20253
January 20261
February 20262
March 20261
April 20260
May 20261
June 20265
July 20261
August 20261
September 20261
October 20260