510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K172593Substantially Equivalent

XCelliStem Wound Powder

Stemsys, Sunrise FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172593 is the FDA 510(k) clearance record for XCelliStem Wound Powder, cleared for Stemsys on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list one 510(k) clearance for Stemsys. As of , FDA records show no recalls naming K172593.

Clearance record

Decision date
Received
(199 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Stemsys 10871 NW 52nd St., Sunrise FL
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