510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K963228Substantially Equivalent for Some Indications

Repliderm Wound Dressing

Orphan Medical, Inc., Minnetonka MN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K963228 is the FDA 510(k) clearance record for REPLIDERM WOUND DRESSING, cleared for Orphan Medical, Inc. on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list one 510(k) clearance for Orphan Medical, Inc. As of , FDA records show no recalls naming K963228.

Clearance record

Decision date
Received
(121 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Orphan Medical, Inc. 13911 Ridgedale Dr., Suite 475, Minnetonka MN
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