510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K192386Substantially Equivalent

KeraStat Cream

Keranetics, Inc., Winston Salem NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192386 is the FDA 510(k) clearance record for KeraStat Cream, cleared for Keranetics on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list 2 510(k) clearances for Keranetics, from to . As of , FDA records show no recalls naming K192386.

Clearance record

Decision date
Received
(317 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Keranetics 200 E. First St., Suite 101, Box#4, Winston Salem NC
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